Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Completed · Phase 3

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01510912

Run by

Iroko Pharmaceuticals, LLC

People needed

602

Starts

2012-01-01

Expected to finish

2013-03-01

Last updated by the study team

2014-05-09

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Premier Research Group - Phoenix — Phoenix, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Acri-Phase I, LLC — Anaheim, California, United States
• Med Center — Carmichael, California, 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
• Well Pharma Medical Research, Corporation — Miami, Florida, United States
• Peninsula Research, Inc — Ormond Beach, Florida, United States
• Alliance Clinical Research — Winter Park, Florida, United States
• Pinnacle Trials, Inc — Atlanta, Georgia, United States
• Drug Studies America — Marietta, Georgia, United States
• Clinical Investigation Specialists, Inc — Gurnee, Illinois, United States
• Heartland Research Associates, LLC — Newton, Kansas, United States
• Clinical Trials Technology Inc — Prairie Village, Kansas, United States
• Professional Research Network of Kansas, LLC — Wichita, Kansas, United States
• Community Research — Crestview Hills, Kentucky, United States
• Quest Research Institute — Bingham Farms, Michigan, United States
• Healthcare Research — Florissant, Missouri, United States
• Sundance Clinical Research, LLC — St Louis, Missouri, United States
• Heartland Clinical Research, Inc — Omaha, Nebraska, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Office of Matthew Barton, MD — Las Vegas, Nevada, United States
• Drug Trials America — Hartsdale, New York, United States
• Clinical Study Center of Asheville, LLC — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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