Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Iroko Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Diclofenac

Study type

Interventional

Funder types

Industry

Identifiers

DIC3-08-06

Details and patient eligibility

About

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.

Enrollment

602 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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