Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
United States121 participantsStarted 2007-08
Plain-language summary
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.
Who can participate
Age range40 Years – 70 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.