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.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|