drugset / Trial / NCT00361582
A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery
Phase 3
Completed
669 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate in patients who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis the efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR patients.
Timeline
- Start
- 2006-10
- Primary completion
- 2007-08
- Completion
- 2007-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tapentadol | Small molecule | 50 mg | Oral |
| Subject | Tapentadol | Small molecule | 75 mg | Oral |