drugset / Trial / NCT00478023
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
Phase 3
Completed
854 enrolled
Grünenthal GmbH
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.
Timeline
- Start
- 2007-05
- Primary completion
- 2008-02
- Completion
- 2008-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine | Other / unclassified | 20 mg | — |
| Subject | Tapentadol | Small molecule | 50 mg | Oral |
| Subject | Tapentadol | Small molecule | 75 mg | Oral |
| Subject | Tapentadol | Small molecule | 100 mg | Oral |
Indications
No indication recorded.