A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

Phase 3 Completed 901 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Grünenthal GmbH · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.

Timeline

Start: 2008-02
Primary completion: 2008-10
Completion: 2008-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Tapentadol 50mg Fixed Dose vs Tapentadol 75mg Fixed Dose vs Oxycodone 10mg Fixed Dose; p <0.001 NCT00613938 ↗

paper The efficacy of tapentadol IR 50 mg and 75 mg was non-inferior to oxycodone HCl IR 10 mg. PMID 19445652 ↗

paper Tapentadol IR 50 mg and 75 mg were non-inferior to oxycodone HCl IR 10 mg for the treatment of acute pain based on the primary efficacy endpoint of SPID(48) PMID 19445652 ↗

Publications

Daniels S, Casson E, Stegmann JU, Oh C, Okamoto A, Rauschkolb C, Upmalis D. A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. Curr Med Res Opin. 2009 Jun;25(6):1551-61. doi: 10.1185/03007990902952825.

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