OBJECTIVE To compare the efficacy of omeprazole (40 mgs/12 h i.v.) and cimetidine (1,200 mgs/i.v./day) in the management of upper gastrointestinal bleeding. METHODS Randomized, prospective open clinical trial. The end points are: mortality, surgical requirements, transfusion requirements, and length of hospitalization in Bleeding Unit and Hospital. METHODS We study patients with upper gastrointestinal bleeding from peptic sources (duodenal ulcer, gastriculcer, acute gastric erosions and peptic esophagitis). 462 patients are evaluated and 282 finally included. RESULTS 151 patients were given cimetidine and 131 omeprazole. No significant differences in any of the end points were found. CONCLUSIONS The use of omeprazole does not improve cimetidine efficacy in the entire group of patients with upper gastrointestinal bleeding.