Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo Pharma Americas, LLC; Sucampo Pharmaceuticals, Inc.
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal

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.