Roxatidine versus ranitidine in the treatment of duodenal ulcer: a randomized, double blind, controlled, multicenter study in Thailand.

ABSTRACT

BACKGROUND: Roxatidine acetate is a novel H2-receptor antagonist and several studies have shown that it is effective in healing duodenal ulcers. We evaluated the efficacy of roxatidine in a non-western society with particular different features and its healing of duodenal ulcers was compared in Thailand with that of ranitidine. METHOD: The design was controlled, randomized, double-blind, and multicenter. The study recruited a total of 215 patients who were endoscoped at the start of the trial and then randomized to receive a single capsule of roxatidine acetate, 150 mg, or an identical capsule containing ranitidine, 300 mg, both to be taken at night. Patients were evaluated at 1, 2, and 4 weeks, including endoscopy at the last session, as well as at 6 weeks with repeat endoscopy if the ulcer had not healed. RESULT: Both drugs relieved pain rapidly, usually within a week, and at repeat endoscopy at 4 weeks most ulcers (78%) were healed, 77.0 and 79.5 per cent in ranitidine and roxatidine, and in those patients in whom healing was not completed the healing rate had risen appreciably to 89.8 and 93.8 per cent respectively at 6 weeks. Small ulcers tended to heal quicker than larger ones, but smoking and alcohol intake had no negative effects on the results. CONCLUSION: The study was valid proof that roxatidine, in a single evening dose of 150 mg, was found to be both safe and effective in the rapid healing of duodenal ulcers when compared with 300 mg ranitidine.