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A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 877 |
| Start date | 2006-07 |
| Completion | 2007-07 |
Conditions
- Osteoarthritis
- Pain Intensity Assessment
- Arthralgia
- Sciatica
- Low Back Pain
Interventions
- CG 5503;tapentadol
Primary outcomes
- The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.