drugset / Trial / NCT00609466
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Phase 3
Completed
291 enrolled
Grünenthal GmbH
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy. This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-02
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine | Other / unclassified | 30 mg | — |
| Subject | Tapentadol | Small molecule | 75 mg | Oral |
Indications
No indication recorded.