Status:
COMPLETED
Open-Label 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 evaluate the safety of Diclofenac \[Test\] Capsules for the treatment of osteoarthritis pain of the knee or hip.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT01510912
Start Date
January 1 2012
End Date
March 1 2013
Last Update
May 9 2014
Active Locations (40)
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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