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news.Sucampo Pharmaceuticals has enrolled the first patient in a multi-center Phase II, dose-finding trial of cobiprostone for the prevention of ulcers and other gastrointestinal injuries in arthritis patients treated with nonsteroidal anti-inflammatory drugs.
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The double-blinded, randomized, placebo-controlled trial will assess cobiprostone (SPI-8811), safety and efficacy in preventing NSAID-induced gastric and duodenal ulcers, erosions and dyspeptic symptoms in patients with arthritis. Sucampo plans to enroll approximately 120 patients with osteoarthritis and/or rheumatoid arthritis at up to 15 sites in the US.
The primary efficacy endpoint for the trial is the overall incidence of gastric ulcers during study treatment. The study will also evaluate secondary endpoints including overall incidence of duodenal ulcers; the change in the number of ulcers and/or erosions (gastric and duodenal) by patient; time-to-onset analysis of ulcer and/or erosion development; and the severity of overall gastrointestinal injury by using a standardized grading scale.
Ryuji Ueno chairman and CEO said: “Based on our preclinical experience with cobiprostone, which has shown the ability to inhibit gastric ulcer formation induced by an NSAID, and its favorable safety profile to date, we believe this compound has the potential to become the standard of care to prevent GI complications associated with NSAID use if it is approved.”