A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.
|ClinicalTrials.gov Identifier: NCT00364247|
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Arthralgia Bunion Hallux Valgus Pain Assessment Tapentadol||Drug: CG5503 IR;tapentadol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||602 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy Followed by a Voluntary Open-Label Extension|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
- The primary effectiveness outcome for this study is SPID48 (i.e., the sum of pain intensity difference at 48 hours relative to the first dose).
- Secondary effectiveness outcomes include, among others, the effect of CG5503 IR on the time to the need for the first rescue pain medication during the double-blind treatment period, and the SPID at 12, 24, and 72 hours relative to first dose.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364247
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|