An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee
|ClinicalTrials.gov Identifier: NCT00211549|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: IDEA-033||Phase 2|
The objective of this double-blind, placebo-controlled, randomized study is to evaluate the safety of and to identify the dose(s) of IDEA-033 that will provide a minimum clinically meaningful effect for treating the signs and symptoms of osteoarthritis of the knee. This study will also compare the safety profile of the three doses of IDEA-033 in treating the signs and symptoms associated with osteoarthritis for 12 weeks. The primary hypothesis is that at least one of the three doses of IDEA-033 is superior to placebo with respect to three primary efficacy endpoints of WOMAC Pain, WOMAC Physical Function, and Subject Global Assessment of Response to Therapy. A second hypothesis is that there is an increase in efficacy with increasing doses of IDEA-033.
Patients will receive one of five treatments for 12 weeks:Three doses of IDEA-033, or naproxen 1 g over-encapsulated tablet + placebo or placebo
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||875 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Doses of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee|
|Study Start Date :||June 2005|
- Change from baseline at Week 12 on pain subscale and physical function subscale on the WOMAC Osteoarthritis Index. Subject global assessment of response to therapy (SGART) on a five-point Likert scale at Week 12.
- Change from baseline at Weeks 2, 6, 9 for WOMAC pain and physical function scores and SGART. Mean change from baseline for the entire on-therapy period for WOMAC pain and physical function scores and SGART.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211549
Show 100 Study Locations
|Study Director:||IDEA AG Clinical Trial||IDEA AG|