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Double‐blind, randomized trial of roxatidine 150 mg in the early evening versus bedtime administration in the short‐term treatment of duodenal ulcer
Author(s) -
LAZZARONI M.,
CANALI A.,
PORRO G. BIANCHI
Publication year - 1995
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.1995.tb00401.x
Subject(s) - bedtime , medicine , evening , tolerability , randomized controlled trial , anesthesia , gastroenterology , adverse effect , physics , astronomy
SUMMARY 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 roxatidine 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 roxatidine at bedtime ( n = 137). Results : After 4 weeks, 78% of patients receiving roxatidine in the early evening and 74% of those treated at bedtime had achieved complete healing, as determined by per‐protocol analysis. With intention‐to‐treat analysis the healing rates were 70.5% and 70.8%, respectively. After 8 weeks the healing rates in the early evening and bedtime treatment groups were 92% and 95% (per‐protocol analysis) and 78% and 84% (intention‐to‐treat analysis). Both treatments proved effective in reducing the frequency and severity of daytime and nocturnal epigastric pain, as well as other ulcer‐related symptoms. Conclusions : 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 duodenal ulcer healing.