Clinical trial
A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in…
NCT00486811 · Grünenthal GmbH, Industry · Completed
Key facts
| NCT number | NCT00486811 |
|---|---|
| Title | 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 |
| Official title | A Randomized Double-blind, Placebo- and Active-control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose 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. |
| Lead sponsor | Grünenthal GmbH, Industry |
| Collaborators | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Pain, Knee Osteoarthritis |
| Intervention type | Drug |
| Interventions | Tapentadol ER (100 to 250 mg twice daily), Matching Placebo (twice daily), Oxycodone CR (20 to 50 mg twice daily) |
| Enrollment | 990 |
| Start date | Jun 1, 2007 |
| Primary completion | Jul 1, 2008 |
| Completion | Jul 1, 2008 |
| First posted | Jun 15, 2007 |
| Last update posted | Oct 18, 2019 |
| Countries | Austria, Croatia, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Slovakia, Spain and 1 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: