Purpose:
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.
Study summary:
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
Criteria:
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