Comparison of Increasing Doses of Tapentadol Versus a Com... | NCT01352741 | Trialant
NCT01352741
Sponsor
Grünenthal GmbH
Status
Completed
Last Update Posted
Oct 28, 2019Actual
Enrollment
622Actual
Phase
Phase 4
Conditions
Low Back Pain
Neuropathic Pain
Interventions
Tapentadol Prolonged Release
Tapentadol Prolonged Release with Pregabalin
Tapentadol Prolonged Release open label maintenance
Countries
Austria
Belgium
Denmark
Germany
Netherlands
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT01352741
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
247251
Secondary IDs
ID
Type
Description
Link
2010-019998-14
EudraCT Number
KF5503/58
Other Identifier
Grünenthal GmbH
Brief Title
Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin
Official Title
Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus a Combination of Tapentadol PR and Pregabalin in Subjects With Severe Chronic Low Back Pain With a Neuropathic Pain Component
Acronym
Not provided
Organization
Grünenthal GmbHINDUSTRY
Status Module
Record Verification Date
Oct 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2011
Primary Completion Date
Jan 2012Actual
Completion Date
Jan 2012Actual
First Submitted Date
Apr 12, 2011
First Submission Date that Met QC Criteria
May 11, 2011
First Posted Date
May 12, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 10, 2016
Results First Submitted that Met QC Criteria
Jun 29, 2016
Results First Posted Date
Aug 12, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 9, 2019
Last Update Posted Date
Oct 28, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Grünenthal GmbHINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main objective of the study is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring additional analgesia after titration to tapentadol PR 300 mg per day.
This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject reported outcomes. Since, severe low back pain with a neuropathic component, the targeted study population, is frequently treated with a combination therapy (monotherapy is often not effective enough) it is of interest to determine if tapentadol alone (combining 2 mechanisms of action in a single molecule) could be as effective as a combination of tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus combination are of interest.
Detailed Description
Participants with a diagnosis of chronic low back pain (defined as pain lasting for at least 3 month) and requiring a strong analgesic (World Health Organization [WHO] Step III) as judged by the investigator and having a positive or unclear score using the painDETECT diagnostic screening questionnaire will enter the open-label titration tapentadol prolonged release (PR) period. In total participants will have 11 planned scheduled visits scheduled over 105 days. At the Enrollment Visit [Day -14 (3 to 14 days prior to the Baseline Visit)] the inclusion and exclusion criteria will be checked to evaluate the participant's eligibility for the trial. Participants on previous analgesics will start a washout period three days up to 2 weeks.The duration of the washout period will depend on previous opioid analgesics and co-analgesics and their respective doses, down-tapering steps. Participants who do not need a washout of previous analgesic treatment (e.g. WHO Step I analgesics), a baseline visit can be scheduled as soon as clinical laboratory monitoring results are available.
At the Baseline Visit (Day 1) participants will start the 3 week open-label titration period tapentadol prolonged release (PR) at doses of 2 x 50 mg per day and will be titrated upwards in steps of 100 mg (2 x 50 mg) on a weekly basis.
Participants who do not qualify for randomization may continue the trial in the open-label continuation arm if they have already reached a satisfactory level of pain relief.
Participants qualifying for randomization in the comparative period (Day 22 to 77) will be allocated to 1 of 2 treatment arms and will continue treatment.
Either they continue on tapentadol prolonged release (PR) with increasing doses of tapentadol PR
After the randomization visit, participants will titrate up to a total daily dose of 400 mg.
1 week after the randomization visit, will titrate up to a total daily dose of 500 mg. Participants in this treatment arm will receive a final dose of 500 mg tapentadol PR per day.
Or start on a combination of tapentadol PR 300 mg per day with pregabalin
After the randomization visit, participants will continue their previous regimen of tapentadol PR 2 x 150 mg per day plus pregabalin 2 x 75 mg (total daily dose of 150 mg pregabalin).
1 week after the randomization visit, participants will continue their previous regimen (end of titration period) of tapentadol PR 2 x 150 mg per day plus pregabalin 2 x 150 mg (total daily dose of 300 mg pregabalin). Participants in this treatment arm will receive a final dose of 300 mg tapentadol PR and 300 mg pregabalin.
Participants in the Comparative Period can be assigned to the open-label pick-up arm and will be treated with a stable dose of tapentadol PR 300 mg per day or 400 mg per day if they experience treatment emergent adverse events (at least possibly related to investigational medicinal product).The open-label pick-up period theoretically starts on Day 29, i.e. one week after the Randomization Visit.
The Final Evaluation (Day 77) is planned to take place 8 weeks after randomization.
After the Final Evaluation a Follow-up Period (blinded tapering down/out of IMP in Week 12 and Follow-up Visit (up to Day 91) will take place. Tapering down/out of medication will be performed according to the Summary of Product Characteristics.
Drug: Tapentadol Prolonged Release open label maintenance
Tapentadol Prolonged Release with Pregabalin
Active Comparator
Tapentadol Prolonged Release (100 - 300 mg per day) with Pregabalin (150 - 300 mg per day) Both administered orally twice a day.
Drug: Tapentadol Prolonged Release with Pregabalin
Drug: Tapentadol Prolonged Release open label maintenance
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tapentadol Prolonged Release
Drug
100 - 500 mg per day orally twice daily for a maximum of 12 weeks
Tapentadol Prolonged Release
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in the Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The primary endpoint is defined as the comparison of tapentadol prolonged release (PR) 300 mg plus 200 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) from the randomization visit to the final evaluation visit.
Theoretically a maximum decrease of -10 and an increase of +4 in the pain intensity would have been possible. A negative sign indicates a decrease in pain intensity from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline visit).
Randomization (Day 22); Final Evaluation Visit (Day 77)
Secondary Outcomes
Measure
Description
Time Frame
Open-label Titration Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)". Where 0 = no pain and 10 indicates pain as bad as you can imagine. This is the treatment period prior to the primary outcome period.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months.
Subject's pain must require a strong analgesic (defined as World Health Organization (WHO) step III) as judged by the investigator.
The painDETECT diagnostic screening questionnaire score must be:
"positive" or
"unclear".or If the subject is being treated with a stable regimen of centrally acting analgesics (opioids) and/or co-analgesics, even a "negative" painDETECT score (but of at least 9) at the enrollment visit will be acceptable.
If under regular daily pretreatment with a WHO step II/step III opioid analgesic and/or a centrally acting co-analgesic:
Subjects must be taking a WHO step II or step III analgesic or co- analgesic on a daily basis for at least 2 weeks prior to the enrollment visit.
Subjects pretreated with a WHO step II opioid analgesic and/or a centrally acting co-analgesic must have reported an average pain intensity score of at least 5 points (NRS-3≥5) during the last 3 days prior to the enrollment visit. or If under regular, daily pretreatment with a WHO step I analgesic monotherapy or if no regular analgesic pretreatment is reported:
Subjects must have an average pain intensity score of at least 6 points NRS-3≥6) in the last 3 days prior to the enrollment visit.
Exclusion Criteria:
Presence of concomitant painful conditions other than low back pain that could confound the subject's trial assessments or self-evaluation of the index pain, e.g., syndromes with widespread pain such as fibromyalgia.
Low back pain caused by cancer and/or metastatic diseases.
Any painful procedures planned during the trial period (e.g., major surgery) that may, in the opinion of the investigator, affect the effectiveness or safety assessments of the Investigational Medicinal Product (IMP).
Pending litigation or application for insurance/governmental benefits due to chronic pain or disability and, if granted, benefits might be influenced by a successful participation in the trial.
Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, lactose intolerance.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ralf Baron, Prof. Dr.
Neurological pain research and therapy Clinic for Neurology Campus Kiel, University Clinic Schleswig-Holstein, Schittenhelmstr. 10, 24105 Kiel, Germany
Baron R, Martin-Mola E, Muller M, Dubois C, Falke D, Steigerwald I. Effectiveness and Safety of Tapentadol Prolonged Release (PR) Versus a Combination of Tapentadol PR and Pregabalin for the Management of Severe, Chronic Low Back Pain With a Neuropathic Component: A Randomized, Double-blind, Phase 3b Study. Pain Pract. 2015 Jun;15(5):455-70. doi: 10.1111/papr.12200. Epub 2014 Apr 17.
622 participants signed an informed consent. All participants included in the 8 week Double Blind Comparative Period were initially in the open-label titration period.
Participants in the open-label tapentadol continuation period were in the open-label titration period but did not enter the comparative period.
Recruitment Details
The trial started on 23 Mar 2011 and the last participant completed the last follow-up examination on the 17 Jan 2012.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tapentadol Prolonged Release
All participants entered the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion. Participants that did not qualify for entry into the Comparative Period were able to enter the open-label Continuation Period. During the double-blind comparator phase the dose was increased to 200 mg twice daily and after a week to 250 mg twice daily. Participants that dropped out due to tolerability issues during the comparative period were able to enter the open-label pick-up arm.
Open-label Continuation Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)". Where 0 = no pain and 10 indicates pain as bad as you can imagine.
End of Open-label Pick-up Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)". Where 0 = no pain and 10 indicates pain as bad as you can imagine.
Final Evaluation Visit (Day 77)
Open-label Titration Period: Radiating Pain
The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.
Open-label Titration Period: Radiating Mean Pain Intensity Score for the Comparative Period Population
The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.
Double-blind Comparative Period: Change in NRS-3 Pain Intensity Score for the Radiating Pain
NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot).
The value reported represents the change from the randomization visit (i.e., the last 3 days in the titration period) to the end of the double-blind comparative period (i.e., the last 3 days in the comparative period). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit).
Randomization Visit (Day 22); End of Evaluation Visit (Day 77)
Open-label Titration Period: Worst Mean Pain Intensity Scores Over the Past 24 Hours
The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit".
Open-label Titration Period: Comparative Double-blind Period Population Worst Mean Pain Intensity Scores Over the Past 24 Hours
The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "pain as bad as you can imagine".
The participant was asked : "Please rate your pain intensity by assessing the one number that best describes your worst pain during the past 24 hours prior to the visit".
Double-blind Comparative Period: Change in Worst Pain Intensity Over the Past 24 Hours
The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit".
A negative change indicates that the pain intensity decreased from the start of the trial.
Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being "negative" (had no neuropathic pain component). A value between 19 and 38 was rated as being "positive" (neuropathic component present). Values from 13 to 18 were scored as being "unclear".
Open-label Titration Period: Comparative Double-blind Period Population painDETECT Assessment
The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being "negative" (had no neuropathic pain component). A value between 19 and 38 was rated as being "positive" (neuropathic component present). Values from 13 to 18 were scored as being "unclear".
Double-blind Comparative Period: Change in painDETECT Final Assessment
The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being "negative" (had no neuropathic pain component). A value between 19 and 38 was rated as being "positive" (neuropathic component present). Values from 13 to 18 were scored as being "unclear". The theoretical range of change in this trial ranged from -38 to 19. A negative change indicated a decrease in their neuropathic component of pain.
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.
Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment in the Double-blind Comparative Period Population
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.
Double-blind Comparative Period: Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. Spontaneous Pressing Pain Subscore). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 10 (100 for the overall score) . A negative change indicates that the intensity of the symptom has decreased since the start of treatment.
Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.
Double-blind Comparative Period: Changes in the Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical summary scores were calculated from the individual responses to those questions covering physical health. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.
The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement.
Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.
Double-blind Comparative Period: Change in Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.
Open-label Titration Period: EuroQol-5 Dimension (EQ-5D) Health Status Index Score for the Double-blind Comparative Period Population
The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating "full health" and 0 representing "dead"). The higher the values (the closer the value is to 1) the better the health status in a treatment group.
Double-blind Comparative Period: Change EuroQol-5 Dimension (EQ-5D) Health Status Index
The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating "full health" and 0 representing "dead"). The higher the values (the closer the value is to 1) the better the health status in a treatment group.
Double-blind Comparative Period: Patient Global Impression of Change (PGIC)
In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale where the patient's rates overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
Double-blind Comparative Period: Clinician Global Impression of Change (CGIC)
In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
Open-label Titration Period: Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A decrease in values over the trial period indicate that there has been an improvement.
Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A negative sign indicates that there has been a decrease in anxiety since the start of treatment.
Open-label Titration Period: Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.
Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the sleep latency.
To assess latency the participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]?
Open-label Titration Period: Sleep Evaluation Questionnaire - Latency in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. Sleep evaluation questionnaire (SQ) items
Double-blind Comparative Period Sleep Evaluation Questionnaire: Change in Latency
The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.
Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Awakenings
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).
The participant was asked at each visit: "How many times did you wake up during the night?"
Open-label Titration Period: Sleep Evaluation - Number of Awakenings in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).
The participant was asked at each visit: "How many times did you wake up during the night?"
Double-blind Comparative Period: Change in the Number of Awakenings
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings. Participants were asked: How many times did you wake up during the night? The change in the Number of Awakenings was calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Final Evaluation Visit (Day 77). A negative change indicates that the number of awakenings in a treatment group have gone down since the Baseline or Randomization Visit. In general pain can interfere with sleep, one potential indicator is the number of awakenings.
Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
Open-label Titration Period: Sleep Evaluation Questionnaire - Time Slept
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
The participant was asked: "How long did you sleep last night?" [Answered in hours and minutes].
Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Hours Slept in the Double-blind Comparative Period Population
The participants were requested to answer the following question:
How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization).
Double-blind Comparative Period: Sleep Evaluation Questionnaire - Change in the Number of Hours Slept
The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Enrollment Visit (Day-12)
Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Baseline Visit (Day 1)
Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Randomization Visit (Day 22)
Double-blind Comparative Period: Change in the Overall Quality of Sleep
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit.
Randomization Visit (Day 22) to Final Evaluation (Day 77)
Open-label Titration Period: Subject's Satisfaction With Treatment
Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:
"How would you rate your overall satisfaction with your current pain treatment?": Excellent, Very Good, Good, Fair and Poor.
End of Open-label Titration Period at Randomization Visit (Day 22)
Double-blind Comparative Period: Subject's Satisfaction With Treatment
Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:
"How would you rate your overall satisfaction with your current pain treatment?": Excellent, Very Good, Good, Fair and Poor.
End of Comparative Period at Final Evaluation Visit (Day 77)
Baron R, Kern U, Muller M, Dubois C, Falke D, Steigerwald I. Effectiveness and Tolerability of a Moderate Dose of Tapentadol Prolonged Release for Managing Severe, Chronic Low Back Pain with a Neuropathic Component: An Open-label Continuation Arm of a Randomized Phase 3b Study. Pain Pract. 2015 Jun;15(5):471-86. doi: 10.1111/papr.12199. Epub 2014 Apr 18.
FG001
Tapentadol Prolonged Release and Pregabalin
At the end of the Open-label Tapentadol Titration Period participants that qualified were randomized to either tapentadol or tapentadol and pregabalin treatment. In this double-blind period participants started on Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
FG000445 subjectsAll participants started with 2 x 50 mg tapentadol PR and titrated upwards in steps of 100 mg/day.
FG0010 subjects
Switched to Open-label Continuation Arm
FG00059 subjects
FG0010 subjects
Full Analysis Set
FG000436 subjects
FG0010 subjects
COMPLETED
FG000372 subjects59 of 73 participants not completing the titration period entered the open-label continuation arm.
FG0010 subjects
NOT COMPLETED
FG00073 subjects
FG0010 subjects
Type
Comment
Reasons
Protocol Violation
FG0004 subjects
FG0010 subjects
Lack of Efficacy
FG00019 subjects
FG0010 subjects
Adverse Event
FG00034 subjects
FG0010 subjects
Withdrawal of consent
FG0007 subjects
FG0010 subjects
Non-compliance with Trial Requirements
FG0005 subjects
FG0010 subjects
Other
FG0004 subjects
FG0010 subjects
Double-blind Comparative Period
Type
Comment
Milestone Data
STARTED
FG000154 subjectsOf the 313 participants that qualified for randomization 154 were randomized to tapentadol.
FG001159 subjects159 of the 313 participants that qualified were randomized to tapentadol and pregabalin treatment.
Switched to Open-label Pick-up Arm
FG00019 subjects
FG00118 subjects
No Pain Assessments Available
FG0002 subjects
FG0012 subjects
Full Analysis Set
FG000152 subjects
FG001157 subjects
Major Protocol Deviations
FG00013 subjects
FG0018 subjects
Per Protocol Set
FG000139 subjects
FG001149 subjects
painDetect Per Protocol Set
FG000109 subjects
FG001127 subjects
SF-12 Per Protocol Set
FG000131 subjects
FG001143 subjects
EQ-5D Per Protocol Set
FG000131 subjects
FG001143 subjects
HADS Per Protocol Set (PPS)
FG000123 subjects
FG001137 subjects
Sleep Evaluation (Latency) PPS
FG000123 subjects
FG001137 subjects
Sleep Evaluations (Awakenings) PPS
FG000123 subjects
FG001137 subjects
Sleep Evaluations (Hours Slept) PPS
FG000123 subjects
FG001137 subjects
COMPLETED
FG000126 subjects
FG001133 subjects
NOT COMPLETED
FG00028 subjects
FG00126 subjects
Type
Comment
Reasons
Protocol Violation
FG0002 subjects
FG0010 subjects
Lack of Efficacy
FG0000 subjects
FG001
Open-Label Tapentadol Continuation Arm
Type
Comment
Milestone Data
STARTED
FG00059 subjects59 of the 73 participants that did not qualify for the comparative period entered this arm.
FG0010 subjectsIn this period no tapentadol PR and pregabalin treatment was planned by the protocol.
Major Protocol Deviation
FG0002 subjects
FG0010 subjects
Full Analysis Set
FG00057 subjects
FG0010 subjects
COMPLETED
FG00051 subjects
FG0010 subjects
NOT COMPLETED
FG0008 subjects
FG0010 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0010 subjects
Lack of Efficacy
FG0001 subjects
FG001
Open-Label Tapentadol Pick-Up Arm
Type
Comment
Milestone Data
STARTED
FG00037 subjects19 from tapentadol in the comparative phase and 18 from tapentadol \& pregabalin entered this arm.
FG0010 subjectsParticipants did not continue treatment. They were switched to tapentadol PR or discontinued.
COMPLETED
FG00037 subjects
FG0010 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Trial Participants
All participants that received at least one dose of tapentadol prolonged release at baseline, in the open-label titration period.
Denominators
Units
Counts
Participants
BG000445
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.9± 11.30
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000262
Male
BG000183
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG000441
Asian
Title
Measurements
BG000
Region of Enrollment
Number
participants
Title
Denominators
Categories
Spain
Title
Measurements
BG00054
Belgium
Title
Measurements
BG000
Height
Data available for 441 participants
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000168.2± 9.97
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00083.61± 17.542
Body Mass Index (BMI)
Data available for 441 participants.
Mean
Standard Deviation
kg/m²
Title
Denominators
Categories
Title
Measurements
BG00029.57± 5.616
Diagnosis of Lumbar Radiculopathy
Number of participants with dermatomal pain present as assessed by the investigator. For a participant to have diagnosed lumbar radiculopathy pain, they must have answered 'yes' to all three dermatomal pain questions and 'yes' to at least one of the three root dysfunction questions
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG000310
No
Title
Measurements
History of low back pain
Participants were asked since when they suffer from their current pain.
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG0006.3(2.1 to 11.7)
Subject's satisfaction with previous treatment
Number
participants
Title
Denominators
Categories
Poor
Title
Measurements
BG000126
Fair
Title
Measurements
BG000
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in the Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The primary endpoint is defined as the comparison of tapentadol prolonged release (PR) 300 mg plus 200 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) from the randomization visit to the final evaluation visit.
Theoretically a maximum decrease of -10 and an increase of +4 in the pain intensity would have been possible. A negative sign indicates a decrease in pain intensity from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline visit).
Double-Blind Comparative Population. Per Protocol Set (PPS).
Posted
Mean
Standard Deviation
units on a scale
Randomization (Day 22); Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
OG000139
OG001149
Title
Denominators
Categories
Title
Measurements
OG000-1.6± 2.52
OG001-1.7± 2.48
Secondary
Open-label Titration Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)". Where 0 = no pain and 10 indicates pain as bad as you can imagine. This is the treatment period prior to the primary outcome period.
Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
Units
Counts
Participants
Secondary
Open-label Continuation Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)". Where 0 = no pain and 10 indicates pain as bad as you can imagine.
Participants that did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day, if they had reached a satisfactory level of pain relief.
Units
Counts
Participants
OG000
Secondary
End of Open-label Pick-up Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)
The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)". Where 0 = no pain and 10 indicates pain as bad as you can imagine.
Observed.
Posted
Mean
Standard Deviation
units on a scale
Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release After Tapentadol
Participants that drop-out of the double-blind tapentadol prolonged release treatment in the Comparative Period, due to tolerability issues, continued on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day in this Open-Label Pick-up arm.
OG001
Tapentadol Prolonged Release After Tapentadol and Pregabalin
Participants that dropped-out of the Tapentadol Prolonged Release and Pregabalin in the double-blind Comparative Period continued with Tapentadol Prolonged Release at either 300 or 400 mg per day in this Open-Label Pick-up arm.
Secondary
Open-label Titration Period: Radiating Pain
The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.
Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration
Units
Counts
Participants
Secondary
Open-label Titration Period: Radiating Mean Pain Intensity Score for the Comparative Period Population
The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Change in NRS-3 Pain Intensity Score for the Radiating Pain
NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot).
The value reported represents the change from the randomization visit (i.e., the last 3 days in the titration period) to the end of the double-blind comparative period (i.e., the last 3 days in the comparative period). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit).
Double-blind comparative population. Per Protocol Set (PPS).
Posted
Mean
Standard Deviation
units on a scale
Randomization Visit (Day 22); End of Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Open-label Titration Period: Worst Mean Pain Intensity Scores Over the Past 24 Hours
The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit".
Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
Units
Counts
Participants
OG000
Secondary
Open-label Titration Period: Comparative Double-blind Period Population Worst Mean Pain Intensity Scores Over the Past 24 Hours
The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "pain as bad as you can imagine".
The participant was asked : "Please rate your pain intensity by assessing the one number that best describes your worst pain during the past 24 hours prior to the visit".
Double-blind comparative population. Per Protocol Set (PPS)
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Secondary
Double-blind Comparative Period: Change in Worst Pain Intensity Over the Past 24 Hours
The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.
The participant was asked: "Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit".
A negative change indicates that the pain intensity decreased from the start of the trial.
Double-blind comparative population. Per Protocol Set (PPS).
Posted
Mean
Standard Deviation
units on a scale
Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being "negative" (had no neuropathic pain component). A value between 19 and 38 was rated as being "positive" (neuropathic component present). Values from 13 to 18 were scored as being "unclear".
Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
Units
Counts
Participants
Secondary
Open-label Titration Period: Comparative Double-blind Period Population painDETECT Assessment
The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being "negative" (had no neuropathic pain component). A value between 19 and 38 was rated as being "positive" (neuropathic component present). Values from 13 to 18 were scored as being "unclear".
Double-blind comparative population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Change in painDETECT Final Assessment
The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being "negative" (had no neuropathic pain component). A value between 19 and 38 was rated as being "positive" (neuropathic component present). Values from 13 to 18 were scored as being "unclear". The theoretical range of change in this trial ranged from -38 to 19. A negative change indicated a decrease in their neuropathic component of pain.
Double-blind comparative population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.
Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
Secondary
Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment in the Double-blind Comparative Period Population
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.
Double-blind comparative population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Secondary
Double-blind Comparative Period: Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. Spontaneous Pressing Pain Subscore). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 10 (100 for the overall score) . A negative change indicates that the intensity of the symptom has decreased since the start of treatment.
Double-blind comparative population. Per Protocol Set (PPS).
Posted
Mean
Standard Deviation
units on a scale
Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Secondary
Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Changes in the Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical summary scores were calculated from the individual responses to those questions covering physical health. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.
The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Change in Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Open-label Titration Period: EuroQol-5 Dimension (EQ-5D) Health Status Index Score for the Double-blind Comparative Period Population
The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating "full health" and 0 representing "dead"). The higher the values (the closer the value is to 1) the better the health status in a treatment group.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Change EuroQol-5 Dimension (EQ-5D) Health Status Index
The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating "full health" and 0 representing "dead"). The higher the values (the closer the value is to 1) the better the health status in a treatment group.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Patient Global Impression of Change (PGIC)
In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale where the patient's rates overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Double-blind comparative population. Full Analysis Set (FAS).
Posted
Number
participants
Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
Secondary
Double-blind Comparative Period: Clinician Global Impression of Change (CGIC)
In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Double-Blind Comparative Population. Full Analysis Set (FAS).
Posted
Number
participants
Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Secondary
Open-label Titration Period: Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A decrease in values over the trial period indicate that there has been an improvement.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.
A negative sign indicates that there has been a decrease in anxiety since the start of treatment.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Open-label Titration Period: Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.
Double-blind Comparative Population; Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the sleep latency.
To assess latency the participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]?
Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
OG001
Baseline Visit (Day 1)
At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
OG002
Randomization Visit (Day 22)
End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
Units
Counts
Secondary
Open-label Titration Period: Sleep Evaluation Questionnaire - Latency in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. Sleep evaluation questionnaire (SQ) items
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Secondary
Double-blind Comparative Period Sleep Evaluation Questionnaire: Change in Latency
The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.
Per Protocol Set (PPS).
Posted
Mean
Standard Deviation
hours
Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
Secondary
Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Awakenings
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).
The participant was asked at each visit: "How many times did you wake up during the night?"
Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
OG001
Baseline Visit (Day 1)
At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
OG002
Randomization Visit (Day 22)
End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
Secondary
Open-label Titration Period: Sleep Evaluation - Number of Awakenings in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).
The participant was asked at each visit: "How many times did you wake up during the night?"
Double-Blind Comparative Population. Per Protocol Set (PPS).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Double-blind Comparative Period: Change in the Number of Awakenings
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings. Participants were asked: How many times did you wake up during the night? The change in the Number of Awakenings was calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Final Evaluation Visit (Day 77). A negative change indicates that the number of awakenings in a treatment group have gone down since the Baseline or Randomization Visit. In general pain can interfere with sleep, one potential indicator is the number of awakenings.
Per Protocol Set (PPS).
Posted
Mean
Standard Deviation
Number of Awakenings
Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Secondary
Open-label Titration Period: Sleep Evaluation Questionnaire - Time Slept
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.
The participant was asked: "How long did you sleep last night?" [Answered in hours and minutes].
Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
OG001
Baseline Visit (Day 1)
At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
OG002
Randomization Visit (Day 22)
End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
Units
Counts
Secondary
Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Hours Slept in the Double-blind Comparative Period Population
The participants were requested to answer the following question:
How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization).
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Secondary
Double-blind Comparative Period: Sleep Evaluation Questionnaire - Change in the Number of Hours Slept
The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
OG001
Baseline Visit (Day 1)
At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
OG002
Randomization Visit (Day 22)
End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
Units
Counts
Secondary
Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Posted
Number
participants
Enrollment Visit (Day-12)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
Secondary
Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Posted
Number
participants
Baseline Visit (Day 1)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
Secondary
Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The participant rated this categorically as being one of the following: excellent, good, fair or poor.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Posted
Number
participants
Randomization Visit (Day 22)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
Secondary
Double-blind Comparative Period: Change in the Overall Quality of Sleep
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.
The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit.
Double-Blind Comparative Population. Per Protocol Set (PPS).
Posted
Number
participants
Randomization Visit (Day 22) to Final Evaluation (Day 77)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
OG001
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
Secondary
Open-label Titration Period: Subject's Satisfaction With Treatment
Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:
"How would you rate your overall satisfaction with your current pain treatment?": Excellent, Very Good, Good, Fair and Poor.
Last Observation Carried Forward (LOCF); Per Protocol Set
Posted
Number
participants
End of Open-label Titration Period at Randomization Visit (Day 22)
ID
Title
Description
OG000
Tapentadol Prolonged Release
Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period.
Units
Counts
Participants
OG000
Secondary
Double-blind Comparative Period: Subject's Satisfaction With Treatment
Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:
"How would you rate your overall satisfaction with your current pain treatment?": Excellent, Very Good, Good, Fair and Poor.
Last Observation Carried Forward (LOCF); Per Protocol Set
Posted
Number
participants
End of Comparative Period at Final Evaluation Visit (Day 77)
ID
Title
Description
OG000
Tapentadol in the Comparative Period
The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
OG001
Tapentadol and Pregabalin in the Comparative Period
Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
Units
Counts
Participants
Time Frame
Baseline Visit; up to end of Week 11.
Description
Treatment Emergent Adverse Events are reported, starting with the first dose in the open-label titration period on Day 1 up to Day 77. TEAEs are reported up to Day 91 at the End of the Follow-Up visit.
One participant died, before the baseline visit, during the washout phase of the clinical trial.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Open-Label Tapentadol Titration Period
During the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion.
Titration dose steps on a weekly basis:
First 50 mg administered twice daily, then 100 mg administered twice daily and then 150 mg administered twice daily.
The titration period could be shortened to 10 days, with a participant at a predefined dose level for at least 3 days.
The dose of 300 mg Tapentadol per day was maintained until the Randomization Visit.
3
445
227
445
EG001
Tapentadol in the Comparative Period
The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
5
154
98
154
EG002
Tapentadol and Pregabalin in the Comparative Period
Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
3
159
103
159
EG003
Open-Label Tapentadol Pick-Up Arm
Participants that drop-out of the Comparative Period, due to tolerability issues, were permitted to continue on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day.
2
37
37
37
EG004
Open-Label Tapentadol Continuation Period
Participants who did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day if they had reached a satisfactory level of pain relief.
2
59
36
59
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG0031 affected37 at risk
EG0040 affected59 at risk
Cardiac failure
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Goitre
Endocrine disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Chest pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Device dislocation
General disorders
MedDRA 14.1
Systematic Assessment
Luxation of new implanted total endoprosthesis left hip
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Muscle contractions involuntary
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG0030 affected37 at risk
EG0040 affected59 at risk
Atrial Fibrillation
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Brachycardia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Cardiovascular Disorder
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Palpitation
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Cupulolithiasis
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Ear Discomfort
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
External Ear Disorder
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Inner Ear Disorder
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Motion Sickness
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Accommodation Disorder
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Atrial Fibrillation
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Dry Eye
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Eye Irritation
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Eye pruritis
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Vision Blurred
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0012 affected154 at risk
EG0020 affected159 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Visual Impairment
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0022 affected159 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0012 affected154 at risk
EG0020 affected159 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0007 affected445 at risk
EG0012 affected154 at risk
EG0022 affected159 at risk
EG003
Abdominal Symptom
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Abnormal Faeces
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Colonic Polyp
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Non-systematic Assessment
EG00025 affected445 at risk
EG00111 affected154 at risk
EG0028 affected159 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG00014 affected445 at risk
EG0016 affected154 at risk
EG0023 affected159 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG00035 affected445 at risk
EG0016 affected154 at risk
EG0028 affected159 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0006 affected445 at risk
EG0011 affected154 at risk
EG0022 affected159 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Flatuence
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Gastrointestinal Disorder
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Inflammatory Bowel Disease
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG00058 affected445 at risk
EG00116 affected154 at risk
EG00214 affected159 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Uvulitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG00020 affected445 at risk
EG0019 affected154 at risk
EG0025 affected159 at risk
EG003
Asthenia
General disorders
MedDRA 14.1
Systematic Assessment
EG0006 affected445 at risk
EG0014 affected154 at risk
EG0020 affected159 at risk
EG003
Chest Discomfort
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Chills
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Discomfort
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Drug Withdrawal Syndrome
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Fatigue
General disorders
MedDRA 14.1
Systematic Assessment
EG00025 affected445 at risk
EG00113 affected154 at risk
EG00216 affected159 at risk
EG003
Feeling Abnormal
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Feeling Cold
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Feeling Drunk
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0022 affected159 at risk
EG003
Feeling Hot
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Gait Disturbance
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Generalised Oedema
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Hyperplasia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Inflammation
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected445 at risk
EG0012 affected154 at risk
EG0023 affected159 at risk
EG003
Irritability
General disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0010 affected154 at risk
EG0023 affected159 at risk
EG003
Malaise
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0006 affected445 at risk
EG0010 affected154 at risk
EG0023 affected159 at risk
EG003
Pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Pyrexia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Thirst
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Abdominal Abscess
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Acute Tonsillitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Bacterial Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Cystitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0012 affected154 at risk
EG0021 affected159 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Ear Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Gastrointestinal Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Herpes Zoster Oticus
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Influenza
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0012 affected154 at risk
EG0021 affected159 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Localised Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0007 affected445 at risk
EG0012 affected154 at risk
EG0025 affected159 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Otitis Media Acute
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0012 affected154 at risk
EG0020 affected159 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Vaginal Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0013 affected154 at risk
EG0024 affected159 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Muscle Rupture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Post Procedural Complication
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Blood Creatinine Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Blood Triglycerides Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0012 affected154 at risk
EG0022 affected159 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Lasegue's Test Positive
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Lipase Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Neurological Examination Abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Nitrite Urine Present
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Prostatic Specifc Antigen Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Protein Urine Present
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Weight Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0013 affected154 at risk
EG0020 affected159 at risk
EG003
White Blood Cell Count Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG00012 affected445 at risk
EG0012 affected154 at risk
EG0021 affected159 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Increased Appetite
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Intervertebral Disc Protusion
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Muscle Fatigue
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Muscle Twitching
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0012 affected154 at risk
EG0020 affected159 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0014 affected154 at risk
EG0023 affected159 at risk
EG003
Sensation of Heaviness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Allodynia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Balance Disorder
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0012 affected154 at risk
EG0022 affected159 at risk
EG003
Carotid Arteriosclerosis
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Disturbance in Attention
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG00051 affected445 at risk
EG00117 affected154 at risk
EG00228 affected159 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0023 affected159 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG00040 affected445 at risk
EG00110 affected154 at risk
EG00213 affected159 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Hyporeflexia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Memory Impairment
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0022 affected159 at risk
EG003
Mental Impairment
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Movement Disorder
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Muscle Contraction Involuntary
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0022 affected159 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0005 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Restless Leg Syndrome
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Sedation
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Sensory Loss
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG00029 affected445 at risk
EG00113 affected154 at risk
EG00219 affected159 at risk
EG003
Speech Disorder
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Tension Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Tremor
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0012 affected154 at risk
EG0022 affected159 at risk
EG003
Abnormal Dreams
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected445 at risk
EG0014 affected154 at risk
EG0023 affected159 at risk
EG003
Apathy
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected445 at risk
EG0013 affected154 at risk
EG0023 affected159 at risk
EG003
Depression
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Drug Dependence
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Emotional Disorder
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Fear
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Food Aversion
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Hallucination, Visual
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Initial Insomnia
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0008 affected445 at risk
EG0013 affected154 at risk
EG0025 affected159 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Listless
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Middle Insomnia
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Mood Swings
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Mood Altered
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0022 affected159 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0005 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Sleep Disorder Due To General Medical Condition, Insomnia Type
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Sleep Talking
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected445 at risk
EG0012 affected154 at risk
EG0022 affected159 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Tic
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Bladder Discomfort
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0023 affected159 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Micturition Disorder
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Renal Cyst
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Breast Swelling
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Sexual Dysfunctio
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0014 affected154 at risk
EG0020 affected159 at risk
EG003
Dry Throat
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0005 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG00021 affected445 at risk
EG00118 affected154 at risk
EG00210 affected159 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0021 affected159 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Pain of Skin
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG00010 affected445 at risk
EG0016 affected154 at risk
EG0021 affected159 at risk
EG003
Pruritus Generalised
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0012 affected154 at risk
EG0021 affected159 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Skin Discolouration
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Skin Tightness
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Tooth Extraction
Surgical and medical procedures
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Blood Pressure Fluctuation
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Flushing
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Haematoma
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Hot Flush
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG00010 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected445 at risk
EG0011 affected154 at risk
EG0025 affected159 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected445 at risk
EG0010 affected154 at risk
EG0022 affected159 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0011 affected154 at risk
EG0020 affected159 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0021 affected159 at risk
EG003
Venous Thrombosis Limb
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected445 at risk
EG0010 affected154 at risk
EG0020 affected159 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The sponsor reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Director of Clinical Trials
Grünenthal GmbH
+49 241 569 3223
ID
Term
D017116
Low Back Pain
D009437
Neuralgia
D000092122
Bronchiolitis Obliterans Syndrome
Ancestor Terms
ID
Term
D001416
Back Pain
D010146
Pain
D009461
Neurologic Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
D010523
Peripheral Nervous System Diseases
D009468
Neuromuscular Diseases
D009422
Nervous System Diseases
D000092124
Organizing Pneumonia
D001989
Bronchiolitis Obliterans
D001988
Bronchiolitis
D001991
Bronchitis
D001982
Bronchial Diseases
D012140
Respiratory Tract Diseases
D008173
Lung Diseases, Obstructive
D008171
Lung Diseases
D006086
Graft vs Host Disease
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069583
Pregabalin
Ancestor Terms
ID
Term
D005680
gamma-Aminobutyric Acid
D000613
Aminobutyrates
D002087
Butyrates
D000144
Acids, Acyclic
D002264
Carboxylic Acids
D009930
Organic Chemicals
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
Adverse Event
FG00016 subjects
FG00117 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
Death
FG0000 subjects
FG0011 subjects
Withdrawal of consent
FG0008 subjects
FG0013 subjects
Other
FG0001 subjects
FG0012 subjects
0 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
2
Other
Title
Measurements
BG0002
45
Poland
Title
Measurements
BG000102
Denmark
Title
Measurements
BG00041
Austria
Title
Measurements
BG00055
Netherlands
Title
Measurements
BG00026
Germany
Title
Measurements
BG000122
BG000134
Missing
Title
Measurements
BG0001
233
Good
Title
Measurements
BG00068
Very Good
Title
Measurements
BG00010
Excellent
Title
Measurements
BG0001
Missing
Title
Measurements
BG0007
OG000445
Title
Denominators
Categories
Enrollment Visit (N=438)
Title
Measurements
OG0007.2± 1.21
Baseline Visit (N=440)
Title
Measurements
OG0008.3± 1.14
Randomization Visit (N=377)
Title
Measurements
OG0005.4± 1.83
59
Title
Denominators
Categories
Enrollment Visit (N=56)
Title
Measurements
OG0007.3± 1.30
Baseline Visit (N=57)
Title
Measurements
OG0007.9± 1.23
Randomization Visit (N=57)
Title
Measurements
OG0002.6± 1.27
Final Evaluation Visit (N=59)
Title
Measurements
OG0002.6± 2.09
Units
Counts
Participants
OG00019
OG00118
Title
Denominators
Categories
Title
Measurements
OG0004.4± 2.83
OG0014.5± 1.96
OG000
445
Title
Denominators
Categories
Enrollment Visit (N=438)
Title
Measurements
OG0007.0± 1.64
Baseline Visit (N=440)
Title
Measurements
OG0008.0± 1.60
Randomization Visit (N=377)
Title
Measurements
OG0005.3± 2.16
Units
Counts
Participants
OG000139
OG001149
Title
Denominators
Categories
Enrollment Visit (N=138; N=149)
Title
Measurements
OG0007.1± 1.75
OG0016.9± 1.49
Baseline Visit (N=139; N=149)
Title
Measurements
OG0008.1± 1.84
OG0018.1± 1.37
Randomization Visit (N=139; N=149)
Title
Measurements
OG0005.6± 1.87
OG0015.7± 1.86
Units
Counts
Participants
OG000139
OG001149
Title
Denominators
Categories
Title
Measurements
OG000-1.5± 2.61
OG001-1.9± 2.60
445
Title
Denominators
Categories
Enrollment Visit (N=438)
Title
Measurements
OG0007.6± 1.32
Baseline Visit (N=440)
Title
Measurements
OG0008.5± 1.11
Randomization Visit (N=377)
Title
Measurements
OG0005.8± 1.98
Participants
OG000139
OG001149
Title
Denominators
Categories
Enrollment Visit (N=138; N=149)
Title
Measurements
OG0007.8± 1.21
OG0017.5± 1.27
Baseline Visit (N=139; N=149)
Title
Measurements
OG0008.5± 1.07
OG0018.7± 0.97
Randomization Visit (N=139; N=149)
Title
Measurements
OG0006.3± 1.52
OG0016.4± 1.4
Counts
Participants
OG000139
OG001149
Title
Denominators
Categories
Title
Measurements
OG000-1.7± 2.67
OG001-1.8± 2.58
OG000
445
Title
Denominators
Categories
Enrollment Visit (N=438)
Title
Measurements
OG00021.4± 5.46
Baseline Visit (N=440)
Title
Measurements
OG00022.7± 5.74
Randomization Visit (N=377)
Title
Measurements
OG00016.9± 6.57
Units
Counts
Participants
OG000139
OG001149
Title
Denominators
Categories
Enrollment Visit (N=138; N=149)
Title
Measurements
OG00021.6± 5.23
OG00121.7± 5.17
Baseline Visit (N=139; N=149)
Title
Measurements
OG00022.4± 5.21
OG00123.8± 5.51
Randomization Visit (N=138; N=149)
Title
Measurements
OG00017.6± 5.93
OG00118.4± 5.90
Units
Counts
Participants
OG000109
OG001127
Title
Denominators
Categories
Change from Baseline
Title
Measurements
OG000-10.2± 8.57
OG001-11.0± 7.73
Change from Randomization
Title
Measurements
OG000-6.0± 8.99
OG001-5.9± 7.22
Units
Counts
Participants
OG000445
Title
Denominators
Categories
Overall Score Enrollment Visit (N=438)
Title
Measurements
OG00055.2± 16.86
Overall Score Baseline Visit (N=440)
Title
Measurements
OG00062.7± 18.41
Overall Score Randomization Visit (N=377)
Title
Measurements
OG00042.0± 20.29
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
Units
Counts
Participants
OG000139
OG001149
Title
Denominators
Categories
Overall Score Enrollment Visit (N=138, N=149)
Title
Measurements
OG00054.8± 15.12
OG00157.6± 16.07
Overall Score Baseline Visit (N=139, N=149)
Title
Measurements
OG00062.8± 17.13
OG00165.4± 18.29
Overall Score Randomization Visit (N=139, N=149)
Title
Measurements
OG00045.2± 17.99
OG00146.5± 18.57
Overall Score Final Evaluation Visit(N=131, N=143)
Title
Measurements
OG00028.9± 21.78
OG00130.5± 22.38
Tapentadol Prolonged Release and Pregabalin
Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.