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Abstract
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, benign gastric ulcer disease. The study end points
(verified by using endoscopy 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 produced comparable reductions in ulcer diameters
and decreases in abdominal pain. Adverse events associated with both roxatidine (27%)
and ranitidine (28%) were headache, diarrhea, and dizziness: rash was associated in
6 of 8 cases and in only 1 case with roxatidine. In this trial, roxatidine 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.
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© 1995 Published by Elsevier Inc.
