A comparison of roxatidine acetate and ranitidine in duodenal ulcer healing.

A randomised double-blind study was conducted to compare the efficacy of roxatidine acetate 75 mg twice daily with ranitidine 150 mg twice daily in 308 patients with endoscopically confirmed uncomplicated duodenal ulcers. After 6 weeks of treatment ulcer healing was found in 93.5% of the roxatidine acetate group and 89.2% of the ranitidine group, with no significant differences between treatment groups. The relief of day and night-time epigastric pain assessed at clinic visits or on diary cards by patients was comparable for both treatment groups, as was the consumption of antacid tablets for relief of symptoms of dyspepsia. There were no significant differences in the healing rates of smokers and non-smokers for either roxatidine acetate or ranitidine treatment, and no clinically significant alterations in laboratory values. Eight patients in the roxatidine acetate group and 1 in the ranitidine group complained of mild side effects, which included diarrhoea, constipation and headache. One patient on roxatidine acetate withdrew from treatment because of a mild skin rash. The results confirm that roxatidine acetate is a safe and effective treatment for duodenal ulcer disease.

RCT Entities:   Population Interventions Outcomes