Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
- Registration Number
- NCT01510912
- Lead Sponsor
- Iroko Pharmaceuticals, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 602
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diclofenac Capsules 35 mg bid or tid Diclofenac -
- Primary Outcome Measures
Name Time Method Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination Baseline to Week 52/Early Termination The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Heartland Research Associates, LLC
🇺🇸Newton, Kansas, United States
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
Clinical Trials Technology Inc
🇺🇸Prairie Village, Kansas, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Sundance Clinical Research, LLC
🇺🇸St Louis, Missouri, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Hypothetest, LLC
🇺🇸Roanoke, Virginia, United States
Clinical Investigation Specialists, Inc
🇺🇸Gurnee, Illinois, United States
Expresscare Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Peninsula Research, Inc
🇺🇸Ormond Beach, Florida, United States
Quest Research Institute
🇺🇸Bingham Farms, Michigan, United States
Healthcare Research
🇺🇸Florissant, Missouri, United States
Premier Research Group - Austin
🇺🇸Austin, Texas, United States
Clinical Investigations of Texas, LLC
🇺🇸Plano, Texas, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Premier Research Group - Phoenix
🇺🇸Phoenix, Arizona, United States
Med Center
🇺🇸Carmichael, California, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Acri-Phase I, LLC
🇺🇸Anaheim, California, United States
Well Pharma Medical Research, Corporation
🇺🇸Miami, Florida, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Alliance Clinical Research
🇺🇸Winter Park, Florida, United States
Pinnacle Trials, Inc
🇺🇸Atlanta, Georgia, United States
Heartland Clinical Research, Inc
🇺🇸Omaha, Nebraska, United States
Office of Matthew Barton, MD
🇺🇸Las Vegas, Nevada, United States
Sterling Research Group, Ltd
🇺🇸Cincinnati, Ohio, United States
Clinical Study Center of Asheville, LLC
🇺🇸Asheville, North Carolina, United States
Triad Clinical Research
🇺🇸Greensboro, North Carolina, United States
Radiant Research, Inc
🇺🇸Anderson, South Carolina, United States
Quality Research Inc
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States