DOUBLE-BLIND, RANDOMIZED TRIAL OF ROXATIDINE 150MG IN THE EARLY EVENING VERSUS BEDTIME ADMINISTRATION IN THE SHORT-TERM TREATMENT OF DUODENAL-ULCER

Aim: To compare the efficacy and tolerability of early evening (19.00- 21.00 hours) vs, bedtime (22.00-00.00 hours) oral administration of ro xatidine 150 mg in the short-term treatment of active duodenal ulcer. Methods: The trial was randomized, double-blind and double-dummy, with parallel groups, A total of 276 patients were recruited and randomly assigned either to roxatidine in the early evening (n = 139) or roxati dine at bedtime (n = 137), Results: After 4 weeks, 78% of patients rec eiving roxatidine in the early evening and 74% of those treated at bed time had achieved complete healing, as determined by per-protocol anal ysis. With intention-to-treat analysis the healing rates were 70.5% an d 70.8%, respectively. After 8 weeks the healing rates in the early ev ening and bedtime treatment groups were 92% and 95%(per-protocol analy sis) and 78% and 84% (intention-to-treat analysis). Both treatments pr oved effective in reducing the frequency and severity of daytime and n octurnal epigastric pain, as well as other ulcer-related symptoms. Con clusions: This study confirmed the healing and analgesic properties of roxatidine in duodenal ulcer disease, Early evening or bedtime dosing with roxatidine 150 mg resulted in similar 4- to 8-week rates of duod enal ulcer healing.