Double-blind, randomized trial of roxatidine 150 mg in the early evening versus bedtime administration in the short-term treatment of duodenal ulcer.
OBJECTIVE
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.
Gastrointestinal Unit, L. Sacco Hospital, Milan, Italy.
M
M
Lazzaroni
A
A
Canali
G
G
Bianchi Porro
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D010880:Piperidines; C053742:roxatidine acetate