Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01461369

Run by

Iroko Pharmaceuticals, LLC

People needed

305

Starts

2011-10-01

Expected to finish

2012-10-01

Last updated by the study team

2014-05-26

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

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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