Dose-response, meal-stimulated gastric antisecretory study of prostaglandin E1 analog, misoprostol, in man.

In a randomized, double-blind, crossover trial, the effects of 50-, 100-, and 200-micrograms doses of misoprostol on meal-stimulated gastric acid secretion were compared with placebo in 16 healthy male subjects. Compared with placebo, the 100- and 200-microgram doses produced significant reductions in acid output for 2 and 3 hr, respectively, following the test meal (P = 0.05). Misoprostol did not influence either the fasting or postprandial serum gastrin levels as compared with placebo. No adverse experiences were reported by any of the subjects. One subject experienced a transient rise in SGPT as compared with baseline, which may have been due to ethanol intake. This study provides a scientific rationale on which to base additional trials of misoprostol in patients with disease related to gastric acid production.

RCT Entities:   Population Interventions Outcomes