drugset
drugset / Trial / NCT00478023

A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy

NCT00478023 ↗

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

Outcome

Met primary endpoint

registry analysis (unspecified test); CG5503 50mg vs Placebo; p <0.0001; Least square mean difference 18.1 (95% CI 10.9 to 25.3); ANCOVA; NCT00478023 ↗

registry analysis (unspecified test); CG5503 75mg vs Placebo; p <0.0001; Least square mean difference 20.8 (95% CI 13.7 to 28.0); ANCOVA; NCT00478023 ↗

registry analysis (unspecified test); CG5503 100mg vs Placebo; p <0.0001; Least square mean difference 23.3 (95% CI 16.3 to 30.4); ANCOVA; NCT00478023 ↗

Drugs

EvaluationDrugModalityDoseRoute
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.