Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Iroko Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Placebo

Drug: Diclofenac

Study type

Interventional

Funder types

Industry

Identifiers

NCT01461369

DIC3-08-05

Details and patient eligibility

About

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.

Enrollment

305 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.