A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery
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|ClinicalTrials.gov Identifier: NCT00361582|
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : June 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Pain Assessment Arthralgia||Drug: CG5503 IR; tapentadol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||669 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 Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
- The primary efficacy outcome is the SPID (Sum of Pain Intensity Difference) calculated at 5 days.
- Secondary efficacy outcomes include, among others, the time to the first use of rescue medication, the distribution of responder rates, and the SPID over 2 and 10 days.
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): NCT00361582
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|