Evaluation of Effectiveness and Tolerability of Tapentado... | NCT00986258

NCT00986258

ID	Type	Description	Link
2009-010428-25	EudraCT Number
KF5503/45	Other Identifier	Sponsor

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Tapentadol Prolonged Release	Experimental	Other Names: Nucynta Palexia	Drug: Tapentadol Prolonged Release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tapentadol Prolonged Release	Drug	Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows: if less than 100 mg morphine equivalent start with 50 mg tapentadol PR; if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR; if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR. Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol PR was reached.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants That Responded to Treatment	Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Average Pain Intensity Before the Start of Tapentadol Treatment	For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".	Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have signed an Informed Consent Form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it.
Participants are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening.
Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.
Participants must be at least 18 years of age.
Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months
If the Participant has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment.
Participant's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
Participants must be taking a WHO Step III analgesic on a daily basis for at least 3 months prior to the Screening Visit.
Participants must have responded to the WHO Step III analgesic, i.e., participants must have a confirmed average pain intensity score (NRS 3) of ≤5 points during the last 3 days prior to the Screening Visit.
Participants must report opioid-related side effects as the reason to change their analgesic.
Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding "fair" on a subject satisfaction with treatment scale (5-point VRS).

Exclusion Criteria:

Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments.
Presence of active systemic or local infection that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments.
History of alcohol or drug abuse, or suspicion of in Investigator's judgement.
Presence of concomitant autoimmune inflammatory conditions.
Known history of or laboratory values reflecting severe renal impairment.
Known history of moderately or severely impaired hepatic function.
History of or active hepatitis B or C within the past 3 months or history of HIV infection.
History of seizure disorder or epilepsy.
Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness.
Pregnant or breast-feeding.
History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including:
Subjects with acute or severe bronchial asthma or hypercapnia.
Subjects who have or are suspected of having paralytic ileus.
Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator.
Participation in another trial concurrently or within 4 weeks prior to the Screening Visit.
Known to or suspected of not being able to comply with the protocol and the use of the investigational medicinal product.
Use of monoamine oxidase inhibitors within 14 days before the Screening Visit.
Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (the doses must remain stable during the trial).
Presence of concomitant painful condition other than low back pain that could confound the subject's trial assessments or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia.
Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments.
Pending litigation due to chronic pain or disability.

Contacts/Locations Module

Name	Affiliation	Role
Michael Schäfer, Prof. MD	Charité University Berlin, Campus Virchow Klinikum	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23475406	Result	Galvez R, Schafer M, Hans G, Falke D, Steigerwald I. Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase 3b study. Adv Ther. 2013 Mar;30(3):229-59. doi: 10.1007/s12325-013-0015-6. Epub 2013 Mar 7.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks.Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

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
	BG00057.1± 12.00

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00076
Male	BG00049

Region of Enrollment

Number

participants

Title

Denominators

Categories

France

Title	Measurements
	BG0001

Czechia

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

Number of Participants That Responded to Treatment

Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.

Per Protocol Set. Last Observation Carried Forward (LOCF).

Posted

Number

participants

6 weeks

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Units	Counts
Participants	OG00094

Title

Denominators

Categories

Title	Measurements
	OG00076

Secondary

Average Pain Intensity Before the Start of Tapentadol Treatment

Intention to Treat

Posted

Mean

Standard Deviation

units on a scale

Baseline

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Units	Counts
Participants

Secondary

Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.

For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity.

Intention to treat (ITT)

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 6 (6 weeks)

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.

For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.

Intention to treat (ITT).

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 12 (12 weeks)

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.

Intention to treat (ITT)

Posted

Number

participants

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Units	Counts
Participants

Secondary

Patient Global Impression of Change

Intention to treat (ITT)

Posted

Number

participants

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Units	Counts
Participants

Secondary

Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (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. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.

Intention to treat (ITT).

For the sub-scores "Role Emotional" and "Role Physical" there were 98 participants, for sub-scores "Physical Functioning", "Vitality" and "Mental Health" there were 99 participants, for sub-score "General Health" there were 100 participants with data available for the change of these sub-scores from baseline to visit 6.

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Change in the Health Survey Scores Form (SF-36)

Intention to Treat (ITT).

For the sub-scores "Role Emotional" and "Role Physical", there were only 91 participants with data available for the change of these sub-scores from baseline to visit 12.

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.

Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group).

Intention to treat (ITT).

For the sub-scores "Overall Score" and "Pressing Pain" there were only 69 participants with data available at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group).

Intention to treat (ITT).

For the sub-scores "Overall Score" and "Pressing Pain" there were only 60 participants with data available at Visit 6.

Posted

Mean

Standard Deviation

units on a scale

End of Week 6

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.

The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group).

Intention to treat (ITT).

Posted

Mean

Standard Deviation

units on a scale

End of Week 12

ID	Title	Description
OG000	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Mean Equipotency Ratio of Tapentadol Compared to Oxycodone

Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.

Intention to treat (ITT). 35 participants with previous oxycodone treatment.

Posted

Number

Ratio

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine

Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine.

Intention to treat (ITT). 24 participants with previous buprenorphine treatment.

Posted

Number

Ratio

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Mean Equipotency Ratio of Tapentadol Compared to Fentanyl

Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl.

Intent to treat (ITT). 22 participants with previous transdermal fentanyl treatment.

Posted

Number

Ratio

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

Mean Equipotency Ratio of Tapentadol Compared to Morphine

Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine.

Intent to treat (ITT). 14 participants with previous morphine treatment.

Posted

Number

Ratio

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Units

Secondary

Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone

Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone.

Intention to treat (ITT). 8 participants with previous hydromorphone treatment.

Posted

Number

Ratio

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Tapentadol prolonged release formulation was administered for up to 12 weeks. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol prolonged release was reached.

Secondary

painDETECT Assessment at Baseline

The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being "negative" (no neuropathic pain component). Value between 19 and 38 as being "positive" (presence of neuropathic component)". Values from 13 to 18 are scored as being "unclear".

Intention to treat (ITT).

Posted

Mean

Standard Deviation

units on a scale

Baseline

ID	Title	Description
OG000	Baseline painDETECT Negative Group	Subgroup of participants with a score between 0 and 12.
OG001	Baseline painDETECT Unclear Group	Subgroup of participants with a score between 13 and 18.
OG002	Baseline painDETECT Positive Group	Subgroup of participants with a score between 19 and 38.

Units	Counts

Secondary

painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment

The baseline painDETECT score was reassessed at the end of Week 6.

It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being "negative" (no neuropathic pain component). Value between 19 and 38 as being "positive" (presence of neuropathic component)". Values from 13 to 18 are scored as being "unclear".

Intention to treat (ITT).

Posted

Mean

Standard Deviation

units on a scale

End of Week 6

ID	Title	Description
OG000	Baseline painDETECT Negative Group	The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
OG001	Baseline painDETECT Unclear Group	The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
OG002	Baseline painDETECT Positive Group	The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.

Secondary

painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment

The baseline painDETECT score was reassessed at the end of Week 12.

Intention to treat (ITT).

Posted

Mean

Standard Deviation

units on a scale

End of Week 12

ID	Title	Description
OG000	Baseline painDETECT Negative Group	The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
OG001	Baseline painDETECT Unclear Group	The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
OG002	Baseline painDETECT Positive Group	The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.

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	Tapentadol Prolonged Release	All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.			11	125	85	125

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Trachycardia	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Chest pain	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Drug withdrawal syndrome	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected125 at risk
Oedema	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
pneumonia	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Headache	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Haematoma	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected125 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0007 affected125 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG00015 affected125 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG00013 affected125 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0008 affected125 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG00019 affected125 at risk
Drug Withdrawal Syndrome	General disorders	MedDRA 13.1	Non-systematic Assessment	EG00026 affected125 at risk
Fatigue	General disorders	MedDRA 13.1	Non-systematic Assessment	EG00013 affected125 at risk
Dizziness	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG00016 affected125 at risk
Headache	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG00018 affected125 at risk
Insomnia	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG00016 affected125 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG00010 affected125 at risk

The results of this trial have to be interpreted under the consideration that it was an open-label trial which was prematurely terminated.

Certain Agreements

ID	Term
D010146	Pain
D059350	Chronic Pain
D017116	Low Back Pain
D009437	Neuralgia
D059226	Nociceptive Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001416	Back Pain
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

ID	Term
D000077432	Tapentadol

Units	Counts
Participants	OG000101

Units	Counts
Participants	OG00093

Units	Counts
Participants	OG00035 OG00120 OG00245

Units	Counts
Participants	OG00033 OG00119 OG00240

Facility	Status	City	State	ZIP	Country	Contacts
BE004		Bruges			Belgium
BE003

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals