A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Conditions: |
Pain Knee Osteoarthritis |
| Interventions: |
Drug: Tapentadol ER (100 to 250 mg twice daily) Drug: Matching Placebo (twice daily) Drug: Oxycodone CR (20 to 50 mg twice daily) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| First participant was enrolled on 04 June 2007 and the last participant out was on 18 July 2008. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo Matching |
Drug: Matching Placebo (twice daily) The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions. |
| Tapentadol ER |
Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance). |
| Oxycodone CR |
Oxycodone CR (20 to 50 mg twice daily). The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance). |
Participant Flow: Overall Study
| Placebo Matching | Tapentadol ER | Oxycodone CR | |
|---|---|---|---|
| STARTED | 337 | 320 [1] | 333 [2] |
| COMPLETED | 215 | 179 | 119 |
| NOT COMPLETED | 122 | 141 | 214 |
| Adverse Event | 28 | 60 | 135 |
| Lack of Efficacy | 34 | 14 | 7 |
| Lost to Follow-up | 4 | 6 | 4 |
| Withdrawal by Subject | 33 | 44 | 58 |
| Study drug non-compliant | 5 | 6 | 3 |
| All other | 18 | 11 | 7 |
| [1] | One participant was not eligible to be dosed. |
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| [2] | Two participants were not eligible to be dosed. |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Placebo Matching |
Drug: Matching Placebo (twice daily) The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions. |
| Tapentadol ER |
Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance). |
| Oxycodone CR |
Oxycodone CR (20 to 50 mg twice daily). The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance). |
| Total | Total of all reporting groups |
Baseline Measures
| Placebo Matching | Tapentadol ER | Oxycodone CR | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
337 | 319 | 331 | 987 |
|
Age
[units: years] Mean ± Standard Deviation |
62.2 ± 9.35 | 62.4 ± 9.35 | 61.8 ± 9.09 | 62.1 ± 9.26 |
|
Age, Customized
[units: participants] |
||||
| Between 18 and 65 years | 194 | 194 | 211 | 599 |
| >=65 years | 143 | 125 | 120 | 388 |
|
Gender
[units: participants] |
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| Female | 257 | 231 | 219 | 707 |
| Male | 80 | 88 | 112 | 280 |
|
Region of Enrollment
[units: participants] |
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| Portugal | 8 | 4 | 3 | 15 |
| Slovakia | 7 | 8 | 9 | 24 |
| Spain | 29 | 23 | 25 | 77 |
| Austria | 14 | 12 | 15 | 41 |
| United Kingdom | 23 | 24 | 28 | 75 |
| Hungary | 36 | 35 | 34 | 105 |
| Poland | 11 | 11 | 13 | 35 |
| Romania | 107 | 103 | 104 | 314 |
| Croatia | 12 | 9 | 8 | 29 |
| Germany | 58 | 60 | 59 | 177 |
| Latvia | 24 | 21 | 24 | 69 |
| Netherlands | 8 | 9 | 9 | 26 |
Outcome Measures
| 1. Primary: | Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). [ Time Frame: Change from baseline over the 12 week Maintenance Period ] |
| 2. Secondary: | Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. [ Time Frame: Change from Baseline to Week 12 of the Maintenance Period ] |
| 3. Secondary: | Patient Global Impression of Change [ Time Frame: Baseline; End of 12 week maintenance period ] |
| 4. Secondary: | Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 [ Time Frame: Change from baseline to week 12 of the maintenance period ] |
| 5. Secondary: | Time to Treatment Discontinuation Due to Lack of Efficacy [ Time Frame: Baseline to week 12 of the maintenance period ] |
| 6. Secondary: | Change in the Health Survey Scores Form (SF-36) [ Time Frame: Change From Baseline to Week 12 of the Maintenance Period ] |
| 7. Secondary: | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time [ Time Frame: Comparison of Baseline to Week 12 of the Maintenance Period ] |
| 8. Secondary: | Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period. [ Time Frame: Week 12 of the maintenance period compared to baseline ] |
| 9. Secondary: | Sleep Questionnaire: Amount of Time Slept in Hours [ Time Frame: Baseline to Week 12 of the maintenance period ] |
| 10. Secondary: | Sleep Questionnaire: Number of Awakenings During Sleep [ Time Frame: Week 12 of the maintenance period compared with baseline ] |
| 11. Secondary: | Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire) [ Time Frame: Week 12 of the maintenance period compared to baseline ] |
| 12. Secondary: | Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time [ Time Frame: Change from Baseline to Week 12 of the Maintenance Period ] |