drugset / Trial / NCT00613938
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
Phase 3
Completed
901 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
Timeline
- Start
- 2008-02
- Primary completion
- 2008-10
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 10 mg | Oral |
| Subject | Tapentadol | Small molecule | 50 mg | Oral |
| Subject | Tapentadol | Small molecule | 75 mg | Oral |