Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Completed · Phase 2 · Has a placebo group

Conditions studied: NSAID-induced Gastroduodenal Injury, Ulcers, Rheumatoid Arthritis, Osteoarthritis

In brief

The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.

Key facts

Study ID

NCT00597818

Run by

Sucampo Pharma Americas, LLC

People needed

121

Starts

2007-08-01

Expected to finish

2009-05-01

Last updated by the study team

2019-12-26

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is more than 40 and less than 70 years of age.
• Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could benefit from NSAID therapy.
• No current gastrointestinal H. pylori infection.

You may not qualify if…

• Known allergy or hypersensitivity to NSAIDs, or has any other contraindicated condition(s) to NSAID therapy.
• Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
• Medical history includes prior or active GI complications and/or disorders, including but not limited to Barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (IBS), or inflammatory bowel disease (IBD).
• Active symptomatic peptic ulcer disease or GI bleeding.
• Patient has received cobiprostone (SPI-8811; RU-8811) or AMITIZA (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.

Where it is running

• Carl T Hayden VA Medical Center — Phoenix, Arizona, United States
• Gregory J. Wiener, MD PC — Chula Vista, California, United States
• Loma Linda University Physicians Medical Group — Loma Linda, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Desert Oasis Healthcare — Palm Springs, California, United States
• Sepulveda Ambulatory Care Center — Sepulveda, California, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• University of Illinois Medical Center — Chicago, Illinois, United States
• Gulf Coast Research, LLC — Baton Rouge, Louisiana, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Long Island Gastrointestinal Research Group — Great Neck, New York, United States
• Research Associates of New York — New York, New York, United States
• University of North Carolina Gastroenterology — Chapel Hill, North Carolina, United States
• Oklahoma Founddation for Digestive Research — Oklahoma City, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Gastroenterology Section at Temple University Hospital — Philadelphia, Pennsylvania, United States
• Dallas VA Research Corporation, Inc. — Dallas, Texas, United States
• Houston Institute for Clinical Research — Houston, Texas, United States
• Digestive and Liver Disease Specialists — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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