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news.Sucampo Pharmaceuticals, an international biopharmaceutical company, has announced that its wholly owned subsidiary, Sucampo Pharma Americas, has completed enrollment of its Phase II clinical trial of cobiprostone designed to evaluate the compound's efficacy and safety for the prevention of ulcers and other gastrointestinal injuries in arthritis patients treated with non-steroidal anti-inflammatory drugs.
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The Phase II trial is a double-blinded, randomized, dose-ranging, placebo-controlled study designed to assess cobiprostone’s efficacy and safety for preventing non-steroidal anti-inflammatory drugs-induced ulcers in patients with arthritis.
Approximately three dose levels of cobiprostone are being tested: 18mcg once a day; 18mcg twice a day; and, 18mcg three times a day for daily totals of 18, 36 and 54mcg, respectively. A fourth cohort of patients will receive matching placebo. All patients in the trial will receive 500mg of naproxen twice a day.
The primary efficacy endpoint for the trial is the overall incidence of gastric ulcers during the 12-week study treatment period. The trial has enrolled a total of 124 patients with osteoarthritis or rheumatoid arthritis at 12 sites in the US.
Ryuji Ueno, chairman and CEO of Sucampo, said: I am pleased to see cobiprostone, Sucampo’s second prostone compound that targets the gastrointestinal tract after lubiprostone, continue to advance in clinical development. If it is successful, cobiprostone would offer patients a preventive treatment regimen.