A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery
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|ClinicalTrials.gov Identifier: NCT00806247|
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : May 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pain Postoperative Pain||Drug: tapentadol HCl||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of CG5503 (Tapentadol) IR for Postoperative Pain Following Bunionectomy Surgery|
|Study Start Date :||January 2005|
|Actual Study Completion Date :||August 2005|
- Primary objective was that at least 1 of the treatment regimens with tapentadol IR was superior to placebo as measured by the sum of total pain relief and sum of pain intensity difference over 12 hours (SPRID12) on the first day after a bunionectomy.
- Secondary objectives included evaluation of several additional pain measures, tolerability to treatments, and drug pharmacokinetics and pharmacodynamics.
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): NCT00806247
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|