| Primary | The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline). | 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 participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity. | Intention to treat. Last Observation Carried Forward (LOCF) | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline; End of Week 6 (6 Weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Patient Global Impression of Change at End of Titration and Optimal Dose Period | 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 |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Patient Global Impression of Change at End of the Maintenance Period | 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 12 (12 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period | The Scores Form 36 (SF-36) includes several brief board 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. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline; End of Week 6 (6 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period | The Scores Form 36 (SF-36) includes several brief board 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. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline; End of Week 12 (12 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| 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 |
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| 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. |
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| Secondary | painDETECT Assessment for Participants at End of Titration and Optimal Dose Period | 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 |
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| 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. |
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| Secondary | painDETECT Assessment for Participants at End of the Maintenance Period | The baseline painDETECT score was reassessed at the end of Week 12. 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 12 | | | | ID | Title | Description |
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| 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. |
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| Secondary | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline | Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales. | Intention to treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline Visit | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period | Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales. | Intention to treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | End of Week 6 | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period | Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales. | Intention to treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | End of Week 12 | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period | Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms. | Intention to treat (ITT), Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline; End of Week 6 (6 Weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period | Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms. | Intention to treat (ITT), Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; End of Week 12 (12 Weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period. | The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is 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 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved. | Intention to treat (ITT). painDETECT negative subpopulation - 35 participants. Unclear and positive painDETECT subpopulation - 98 participants. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline; End of Week 6 (6 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period. | EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement. | Intention to treat (ITT). painDETECT negative subpopulation - 34 participants. Unclear and positive painDETECT subpopulation - 97 participants. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline; End of Week 6 (6 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period | The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is 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 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved. | Intention to treat (ITT). Unclear and positive painDETECT subpopulation - 66 participants. painDETECT negative subpopulation - 23 participants. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; End of Week 12 (12 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period | EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement. | Intention to treat (ITT). painDETECT negative subpopulation - 23 participants. Unclear and positive painDETECT subpopulation - 66 participants. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline; End of Week 12 (12 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period | In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician 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 |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Clinical Global Impression of Change (All Participants) at End of Maintenance Period | In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician 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 12 (12 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement. | Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement. | Negative painDETECT subpopulation - 34 participants Unclear and positive painDETECT subpopulation - 94 participants Intention to Treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; End of Week 6 (6 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period | Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement. | Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants Intention to Treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; End of Week 12 (12 Weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Hospital Anxiety Depression Scale: Depression Score at Baseline | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement. | Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period. | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement. | Negative painDETECT subpopulation - 34 participants Unclear or positive painDETECT subpopulation - 94 participants Intention to Treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; End of Week 6 (6 weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period | Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement. | Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants. Intention to Treat (ITT). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; End of Week 12 (12 Weeks) | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period. | Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial. | Negative painDETECT subpopulation - 22 participants Unclear painDETECT subpopulation - 15 participants Positive painDETECT subpopulation - 22 participants Intention to treat (ITT). | Posted | | Mean | Standard Deviation | milligrams (mg) | | Week 6 | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Participant's Satisfaction With Previous Analgesic Treatment at Baseline | Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor. | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period. | Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor. | Intention to treat (ITT). | Posted | | Number | | participants | | End of Week 6 | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period. | Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor. | Intention to treat (ITT). | Posted | | Number | | participants | | End of Week 8 | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period. | Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor. | Intention to treat (ITT). | Posted | | Number | | participants | | End of Week 12 | | | | ID | Title | Description |
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| OG000 | Tapentadol | All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline. | 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". | Intention to treat (ITT). Negative painDETECT subpopulation - 31 participants. Unclear and positive painDETECT subpopulation - 56 participants | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Tapentadol | Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants that entered the titration and optimal dose period. All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | 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". | Intention to treat (ITT). Negative painDETECT subpopulation - 22 participants. Unclear and positive painDETECT subpopulation - 37 participants | Posted | | Mean | Standard Deviation | Units on a scale | | End of Week 6 | | | | ID | Title | Description |
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| OG000 | Tapentadol | NRS-3 pain intensity values at End of Week 6 in PainDetect specific subgroup of participants that entered the titration and optimal dose period. All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period. | 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". | Intention to treat (ITT). Negative painDETECT subpopulation - 15 participants. Unclear and positive painDETECT subpopulation - 24 participants | Posted | | Mean | Standard Deviation | Units on a scale | | End of Week 12 | | | | ID | Title | Description |
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| OG000 | Tapentadol | NRS-3 pain intensity values at End of Week 12 in PainDetect specific subgroup of participants that entered the maintenance period. All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline. | 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". | Intention to treat (ITT). Negative painDETECT subpopulation - 18 participants. Unclear and positive painDETECT subpopulation - 70 participants | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Tapentadol | Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period. |
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| Secondary | NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period. | 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". | Intention to treat (ITT). Negative painDETECT subpopulation - 13 participants. Unclear and positive painDETECT subpopulation - 62 participants | Posted | | Mean | Standard Deviation | Units on a scale | | End of Week 6 | | | | ID | Title | Description |
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| OG000 | Tapentadol | NRS-3 pain intensity values at end of Week 6 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period. All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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| Secondary | NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period. | 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". | Intention to treat (ITT). Negative painDETECT subpopulation - 8 participants. Unclear and positive painDETECT subpopulation - 42 participants | Posted | | Mean | Standard Deviation | Units on a scale | | End of Week 12 | | | | ID | Title | Description |
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| OG000 | Tapentadol | NRS-3 pain intensity values at End of Week 12 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the maintenance period. All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 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 hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total. |
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