A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety

Phase 3 Terminated 367 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Grünenthal GmbH · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.

Timeline

Start: 2006-10
Primary completion: 2007-12
Completion: 2007-12

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
Subject	Tapentadol	Small molecule	100 mg	Oral

Indications

No indication recorded.