COMPARISON OF THE EFFICACY AND SAFETY OF EBROTIDINE IN THE TREATMENT OF DUODENAL-ULCER - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE-II STUDY

Ebrotidine ethyl]amino]methylene]-4-bromo-benzenesulfonamide, CAS 1009 81-43-9, FI-3542) is a new H-2-receptor antagonist characterized by it s high receptor affinity and gastroprotective effect. This Phase II st udy has been undertaken to establish the efficacy and safety of ebroti dine, administered in four dosages as a single evening dose versus pla cebo in the treatment of duodenal ulcer. A total of 110 duodenal ulcer patients were studied in a randomized, double-blind, placebo-controll ed, multicentre clinical trial. The patients were assigned to 5 groups : placebo, 200 mg, 400 mg, 600 mg and 800 mg of ebrotidine once daily. Controls were performed at baseline and every two weeks at four follo w-up visits unless ulcer healed before. Endoscopic examination was the main parameter for the assessment of treatment efficacy and ulcer hea ling rate. Vital signs and blood/urine analysis were used to establish safety. The three groups treated with higher dosages (400 to 800 mg o f ebrotidine daily) showed an endoscopic ulcer healing rate of 90-95%, significantly higher than 55% achieved with placebo (p < 0.05), whils t the differences between these three dosages of ebrotidine were not s tatistically significant. Heating rate in the group treated with 200 m g of ebrotidine daily was not significantly different from that in the placebo group. The development of symptoms, number of episodes of ulc er-related pain, total ulcerated surface area or subjective ratings by the patients and investigators also differed significantly between eb rotidine (400, 600 and 800 mg daily) and placebo, and again, no marked differences were found between these three doses of ebrotidine. As fa r as tolerance is concerned, no clinically or statistically significan t changes were observed in vital signs and analytical parameters. The incidence of side effects was less than that presented by the placebo group, possibly due to a greater consumption of antacids in this group . Results showed that a daily dose of 400 mg ebrotidine is effective a nd safe in the treatment of duodenal ulcers.