Role of nocturnal acid suppression on the rate of duodenal ulcer healing: clinical dose-range trials with oxmetidine.
These studies represent the first attempt to compare, concurrently, several once or twice daily dosage regimens of an H2-receptor antagonist for ulcer-healing efficacy in the same national population within the same time period, using the same criteria for patient selection, duration of treatment, and end-point. Investigators from 66 centers entered 745 patients, 17-71 years of age, with endoscopically documented uncomplicated duodenal or pyloric channel ulcers, greater than or equal to 0.5 cm in the longest axis. Patients were randomly assigned to six regimens (five oxmetidine, one placebo) and were dosed once (bedtime) or twice (morning and bedtime) daily. Antacid use was restricted. Endoscopy was performed at wk 0 and 2, and at wk 4 in patients not healed at wk 2. Statistical analysis at wk 4 revealed the following healing rates with oxmetidine: 400 mg bid-73.3%; 600 hs-71%; 400 hs-68.6 and 61.6%; 200 mg bid-61.5%; and 200 hs-59.9%. All of the regimens except 200 hs were statistically significantly superior to placebo. The efficacy of the nocturnal 600-mg dose was comparable to that of 400 mg bid and the efficacy of the nocturnal 400-mg dose was comparable to that of 200 mg bid.
D000293:Adolescent; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003404:Creatinine / Q000097:blood; D004334:Drug Administration Schedule; D004381:Duodenal Ulcer / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos; D011897:Random Allocation
D007093:Imidazoles; D010919:Placebos; D003404:Creatinine; C027703:oxmetidine