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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IDEA AG
• Treatments: Naproxen

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