Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Launched by SUCAMPO PHARMA AMERICAS, LLC · Jan 17, 2008

Keywords

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Gender

ALL

Eligibility criteria

• 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.