A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip
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|ClinicalTrials.gov Identifier: NCT00325858|
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : August 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Tramadol HCl ER||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Double-Blind, Randomized,Dose-Ranging, Parallel-Group Comparison Of The Efficacy And Safety Of Extended-Release Tramadol Hydrochloride(Tramadol HCl ER)100 Mg, 200 Mg, 300 Mg, And 400 Mg With Placebo In The Treatment Of Osteoarthritis Of Knee And/Or Hip|
|Study Start Date :||January 2002|
|Study Completion Date :||December 2003|
- The primary outcome is the change from baseline to Week 12 in the WOMAC OA Index pain and physical function subscale scores and the patient global assessment of disease activity.
- The secondary outcomes include: the change from baseline in the daily arthritis pain intensity scores from patient diaries; WOMAC OA stiffness subscale score, OA pain intensity VAS for index and non-index joints, and Chronic Pain Sleep Inventory scale.
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): NCT00325858
|United States, Pennsylvania|
|Altoona Center for Clinical Research|
|Duncansville, Pennsylvania, United States, 16635|