A MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARISON OF ROXATIDINE WITHRANITIDINE IN THE TREATMENT OF PATIENTS WITH UNCOMPLICATED BENIGN GASTRIC-ULCER DISEASE

Roxatidine (150 mg, 312 patients) was compared with ranitidine (300 mg , 308 patients) in a randomized, double-blind, parallel-group, 6-week therapeutic study for the treatment of patients with uncomplicated, be nign gastric ulcer disease. The study end points (verified by using en doscopy results) were fully healed ulcers at 4 or 6 weeks. The results of roxatidine therapy were comparable to those of ranitidine therapy: healing rates of 52% and 54% at week 4 and 77% and 76% at week 6 were recorded for roxatidine and ranitidine, respectively. The drugs produ ced comparable reductions in ulcer diameters and decreases in abdomina l pain. Adverse events associated with both roxatidine (27%) and ranit idine (28%) were headache, diarrhea, and dizziness; rash was associate d in 6 of 8 cases and in only 1 case with roxatidine. In this trial, r oxatidine 150 mg once daily was as efficacious and safe as ranitidine 300 mg once daily for treatment of patients with uncomplicated, benign gastric ulcer disease.