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.