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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002943-11 | EudraCT Number |
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This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with a neuropathic pain component.
Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapentadol Prolonged Release (PR) | Experimental |
| |
| Oxycodone/Naloxone Prolonged Release | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol Prolonged Release | Drug | All participants started with 50 mg tapentadol hydrochloride prolonged release (twice daily). The dose of tapentadol hydrochloride prolonged release will be adjusted in increments of 50 mg to a level that provided adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants are permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3) | For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). 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). | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score | The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing). | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Recalled Average Pain Intensity | The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. 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)". |
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Inclusion Criteria:
Inclusion criteria prior to allocation to treatment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director Clinical Trials | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AT001 | Senftenberg | 3541 | Austria | |||
| AT002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26095455 | Result | Baron R, Likar R, Martin-Mola E, Blanco FJ, Kennes L, Muller M, Falke D, Steigerwald I. Effectiveness of Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR for the Management of Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-Label, Phase 3b/4 Study. Pain Pract. 2016 Jun;16(5):580-99. doi: 10.1111/papr.12308. Epub 2015 Jun 12. |
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367 participants signed informed consent. 89 participants did not meet the inclusion/exclusion criteria, 16 participants withdrew and 4 participants left the trial for other reasons.
Participants randomized to oxycodone/naloxone PR could be switched to tapentadol PR treatment in the pick-up arm of the trial.
The trial started on 22 Mar 2013 with the enrollment of the first participant and was completed on 28 Jan 2014 when the last subject completed the last follow-up examination according to the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tapentadol Prolonged Release | All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Period |
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| Oxycodone/Naloxone Prolonged Release | Drug | All participants start with 10 mg/5 mg oxycodone/naloxone (twice daily). The dose of oxycodone/naloxone may be adjusted in increments of 10mg/ 5 mg oxycodone/naloxone to a level that provide adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants will be permitted a maximum dose of 50 mg/ 20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks. |
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| Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in Recalled Average Pain Intensity at the End of Treatment | The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 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)". 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). | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg | Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve. The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic. The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment | Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve. Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic. The recalled average 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. A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| 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" | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| 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 15. A negative change indicated a decrease in their neuropathic component of pain. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in painDETECT Final Assessment at the End of Treatment | 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 15. A negative change indicated a decrease in their neuropathic component of pain. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| 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. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. 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 1. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment | 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 1. 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 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Short Form Health Survey (SF-12) | 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 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Changes in the Short Form Health Survey (SF-12) at the End of Treatment | 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 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 since starting the trial. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| EuroQol-5 (EQ-5D) Health Status Index Outcome | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Hospital Anxiety and Depression Scale: Anxiety | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Hospital Anxiety and Depression Scale: Depression | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Patient Global Impression of Change at the End of Treatment | In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Clinician Global Impression of Change at the End of Treatment | 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." | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Sleep Evaluation at the End of Treatment: 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 participant rated this categorically as being one of the following: excellent, good, fair or poor. The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Sleep Evaluation: Number of Awakenings | The participants were requested to answer the following question: 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) and for the night prior to the End of the Continuation Visit (12 weeks after randomization). | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings | The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Sleep Evaluation: Number of Hours Slept | 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). | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Sleep Evaluation at the End of Treatment: 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Sleep Evaluation: Latency (Time Taken to Fall Asleep) | 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. | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
| Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep) | 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 (Randomization Visit); End of Continuation Visit (Week 12) |
| Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids | In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest. The composition score from participant who reported: Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated. | Baseline (Randomization Visit) to End of Titration Period (End of Week 3) |
| Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids | In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest. The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated. | Baseline (Randomization Visit); End of Week 3 (End of Titration Period) |
| Vienna |
| 1100 |
| Austria |
| DE005 | Bad Saarow | 15526 | Germany |
| DE007 | Berlin | 10435 | Germany |
| DE021 | Berlin | 10787 | Germany |
| DE009 | Berlin | 12627 | Germany |
| DE030 | Berlin | 13125 | Germany |
| DE020 | Bochum | 44787 | Germany |
| DE023 | Böhlen | 04564 | Germany |
| DE029 | Cologne | 50924 | Germany |
| DE008 | Cologne | 51069 | Germany |
| DE028 | Cottbus | 03050 | Germany |
| DE012 | Dresden | 01067 | Germany |
| DE032 | Essen | 45355 | Germany |
| DE017 | Frankfurt | 60313 | Germany |
| DE003 | Frankfurt | 60596 | Germany |
| DE011 | Görlitz | 02826 | Germany |
| DE031 | Hamburg | 20253 | Germany |
| DE013 | Hanover | 30159 | Germany |
| DE001 | Kiel | 24105 | Germany |
| DE027 | Kiel | 24106 | Germany |
| DE014 | Kiel | 24119 | Germany |
| DE004 | Leipzig | 04103 | Germany |
| DE034 | Leipzig | 04107 | Germany |
| DE018 | Leipzig | 04109 | Germany |
| DE015 | Magdeburg | 39104 | Germany |
| DE006 | Mainz | 55116 | Germany |
| DE002 | Mittweida | 09648 | Germany |
| DE010 | Rudolstadt | 07407 | Germany |
| DE025 | Schwerin | 19055 | Germany |
| DE019 | Stadtroda | 07646 | Germany |
| DE016 | Weinheim | 69469 | Germany |
| DE024 | Westerstede | 26655 | Germany |
| DE026 | Wiesbaden | 65185 | Germany |
| DE022 | Wiesbaden | 65187 | Germany |
| IT003 | Catania | 95125 | Italy |
| IT001 | Genova | 16132 | Italy |
| IT002 | Parma | 43126 | Italy |
| IT004 | Pavia | 27100 | Italy |
| IT005 | Varese | 21046 | Italy |
| ES006 | A Coruña | 15006 | Spain |
| ES007 | Barcelona | 08006 | Spain |
| ES001 | Barcelona | 08916 | Spain |
| ES003 | Centelles | 08540 | Spain |
| ES008 | Guadix | 18500 | Spain |
| ES002 | Madrid | 28046 | Spain |
| ES010 | Madrid | 28050 | Spain |
| ES009 | Madrid | 28850 | Spain |
| ES004 | Oviedo | 33009 | Spain |
| ES005 | Santiago de Compostela | 15705 | Spain |
| FG001 | Oxycodone/Naloxone Prolonged Release | All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
| No Post Baseline Pain Intensity Values |
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| Major Protocol Deviations |
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| Switched to Pick-up Arm |
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| Full Analysis Set |
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| Per Protocol Set |
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| COMPLETED |
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| NOT COMPLETED |
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| Continuation Period |
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| Pick-up Arm |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tapentadol Prolonged Release | All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
| BG001 | Oxycodone/Naloxone Prolonged Release | All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Dermatol pain present | Number | participants |
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| Lumbar radiculopathy | Number | participants |
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| Duration of pain [months] | Median | Full Range | months |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilogram |
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| painDETECT | 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". Participants being treated with a stable regimen of centrally acting co-analgesics at baseline were permitted if the score was at least 9. | Number | participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3) | For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). 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). | The primary analysis was performed for the Per Protocol Set (PPS). Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Primary | Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score | The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing). | The primary analysis was performed for the Per Protocol Set (PPS). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Recalled Average Pain Intensity | The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. 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)". | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change in Recalled Average Pain Intensity at the End of Treatment | The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 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)". 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). | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg | Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve. The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic. The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment | Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve. Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic. The recalled average 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. A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | 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" | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment | 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. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | 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 15. A negative change indicated a decrease in their neuropathic component of pain. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change in painDETECT Final Assessment at the End of Treatment | 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 15. A negative change indicated a decrease in their neuropathic component of pain. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | 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. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. 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 1. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment | 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 1. 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 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Short Form Health Survey (SF-12) | 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 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. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Changes in the Short Form Health Survey (SF-12) at the End of Treatment | 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 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 since starting the trial. | Full Analysis Set (FAS), Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | EuroQol-5 (EQ-5D) Health Status Index Outcome | 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. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment | 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. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Hospital Anxiety and Depression Scale: Anxiety | 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. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety | 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. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Hospital Anxiety and Depression Scale: Depression | 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. | Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression | 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. | Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Patient Global Impression of Change at the End of Treatment | In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Number | participants | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Clinician Global Impression of Change at the End of Treatment | 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." | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). | Posted | Number | participants | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Sleep Evaluation at the End of Treatment: 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 participant rated this categorically as being one of the following: excellent, good, fair or poor. The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). | Posted | Number | participants | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Sleep Evaluation: Number of Awakenings | The participants were requested to answer the following question: 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) and for the night prior to the End of the Continuation Visit (12 weeks after randomization). | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Mean | Standard Deviation | number of awakenings | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings | The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available. | Posted | Least Squares Mean | Standard Error | number of awakenings | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Sleep Evaluation: Number of Hours Slept | 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). | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | hours | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Sleep Evaluation at the End of Treatment: 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. | Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | hours | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Sleep Evaluation: Latency (Time Taken to Fall Asleep) | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | hours | Baseline (Randomization Visit); End of Continuation Period (Week 12) |
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| Secondary | Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep) | 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. | Full Analysis Set (FAS). Last Observation carried Forward (LOCF). Number of participants taken into account for the analyses. | Posted | Least Squares Mean | Standard Error | hours | Baseline (Randomization Visit); End of Continuation Visit (Week 12) |
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| Secondary | Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids | In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest. The composition score from participant who reported: Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated. | Safety Set (SAF). | Posted | Number | participants | Baseline (Randomization Visit) to End of Titration Period (End of Week 3) |
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| Secondary | Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids | In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest. The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated. | Safety Set (SAF). | Posted | Number | number of events | Baseline (Randomization Visit); End of Week 3 (End of Titration Period) |
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Adverse events occurring after first administration of study drug were listed (Treatment emergent adverse events - TEAEs) and within 3 days after the last intake were considered as TEAEs. Pre-treatment adverse events that worsened were considered TEAEs.
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| 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 (PR) | All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. | 3 | 130 | 97 | 130 | ||
| EG001 | Oxycodone/Naloxone Prolonged Release (PR) | All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. | 2 | 128 | 105 | 128 | ||
| EG002 | Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment | Participants in the oxycodone/naloxone PR treatment arm that did not reach the minimum target of titration or experiencing intolerable side effects at the end of the Titration Period could be switched to the Pick-up Arm. They could also enter the Pick-up Arm at any time during the Titration Period or Continuation Period, via an unscheduled visit, due to lack of tolerability or lack of efficacy under treatment with oxycodone/naloxone PR. Participants were directly switched from oxycodone/naloxone PR to tapentadol PR using an equianalgesic ratio of 1:5 (oxycodone : tapentadol), together with a down-titration step under tapentadol PR (except for participants on oxycodone/naloxone PR 10 mg/5 mg twice daily). | 0 | 50 | 29 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Tachycardia paroxysmal | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Saliva altered | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Local swelling | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Thirst | General disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urinary tract Infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Biopsy chest wall | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood testosterone decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neck pain | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Myosclerosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neuromuscular blockade | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Orthostatic intolerance | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vertigo cns origin | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Claustrophobia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Withdrawal syndrome | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Haematidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vocal cord polypectomy | Surgical and medical procedures | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Grünenthal GmbH | +49 241 569 | 3223 | Clinical-Trials@grunenthal.com |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| D009437 | Neuralgia |
| D003248 | Constipation |
| ID | Term |
|---|---|
| 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 |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Technical problems |
|
| Withdrawal by Subject |
|
| Technical problems |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| Germany |
|
| painDETECT unclear |
|
| painDETECT negative |
|
| OG001 | Oxycodone/Naloxone Prolonged Release | All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
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All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
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All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
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All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
|
|
| OG001 | Oxycodone/Naloxone Prolonged Release | All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
|
|
| OG001 | Oxycodone/Naloxone Prolonged Release | All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
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| Oxycodone/Naloxone Prolonged Release |
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. |
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All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
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