Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of Diclofenac [Test] Capsules for the treatment of osteoarthritis pain of the knee or hip.

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

Details

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

Criteria

Inclusion Criteria:

• Male or female ≥ [greater than or equal to] 40 years of age

• If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety

• Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain

• Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening

Exclusion Criteria:

• Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac

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

• Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease

• Has significant difficulties swallowing capsules or is unable to tolerate oral medication