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

Outcome

Met primary endpoint

registry analysis (superiority or other test); CG5503 vs Placebo; p <0.0001; Least square mean 70.8 (95% CI 35.9 to 105.6); ANCOVA; note: No multiplicity adjustment used. NCT00609466 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Morphine	Other / unclassified	30 mg	—
Subject	Tapentadol	Small molecule	75 mg	Oral

Indications

No indication recorded.