Study of Diclofenac Capsules to Treat Osteoarthritis Pain

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iroko Pharmaceuticals, LLC
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• Primary diagnosis of Functional Class I-III OA of the hip or knee with documented osteoarthritis flare at baseline

• Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain

• Discontinued all analgesic therapy at Screening

• For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

Exclusion Criteria:

• History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDS, including diclofenac

• Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip

• Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease

• Significant difficulties swallowing capsules or unable to tolerate oral medication

• Previous participation in another clinical study of Diclofenac Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening.