Overview

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.