Status:
COMPLETED
Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Lead Sponsor:
Iroko Pharmaceuticals, LLC
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT01461369
Start Date
October 1 2011
End Date
October 1 2012
Last Update
May 26 2014
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Premier Research Group - Phoenix
Phoenix, Arizona, United States, 85027
2
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
3
Acri-Phase I, LLC
Anaheim, California, United States, 92801
4
Med Center
Carmichael, California, United States, 95608