A 4-week, multicenter, duodenal ulcer healing trial comparing four escalating doses of ranitidine.

Abstract

In a randomized double-blind 4-wk trial, ranitidine doses of 300 mg at bedtime (hs), twice daily (bid), three times daily (tid), and four times daily (qid) were compared in 629 patients with endoscopically confirmed duodenal ulcer(s). Endoscopies were performed at baseline and after 4 wk of therapy. Per protocol analysis revealed wk 4 healing rates that were significantly increased (p < or = 0.001) for the bid, tid, and qid groups, compared with the hs group. All treatments provided early symptomatic (ulcer pain) relief. No significant differences in adverse events or laboratory abnormalities were observed between groups. Ranitidine 300 mg bid provides an alternative therapeutic approach for patient populations at risk for ulcer complications. These patients include those with the following: a past history of an upper gastrointestinal hemorrhage, perforation, obstruction, penetration, or giant (> 2.0 cm) duodenal ulcer. The elderly and those with chronic unresponsive ulcerations may also be included in this population.