An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee

An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee

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

The purpose of this study is to identify the dose(s) of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee.

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

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.

Inclusion Criteria: Osteoarthritis of both knees for minimum of six months Moderate pain in the most involved knee when not taking NSAIDs Must have used an oral NSAID on at least three days per week for last three months or 25 of 30 days before screening Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months Exclusion Criteria: Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria Intra-articular injections or arthroscopy of the most involved knee during three months before Screening visit Inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection A large bulging effusion History of gout or pseudo-gout induced synovitis or infection of the more severe knee History of partial or total knee replacement in either knee