EBROTIDINE VERSUS RANITIDINE IN THE HEALING AND PREVENTION OF RELAPSEOF DUODENAL-ULCER - A MULTICENTER, DOUBLE-BLIND, PARALLEL, RANDOMIZED, CONTROLLED-STUDY

Two hundred and fifty patients were included in a double-blind, parall el, randomized, controlled clinical trial. Duodenal ulcer treatment la sted up to 8 weeks. Forty-nine patients were followed up for preventio n of ulcer relapse for up to one year. All patients received either ra nitidine (300 mg/day in the healing phase and 150 mg/day in the follow -up phase) or ebrotidine ethyl]amino]methylene]-4-brome-benzenesulfona mide, CAS 100981-43-9, FI-3542) (400 mg/day in both phases) as a singl e dose at bedtime. Both groups were matched in all demographic paramet ers, except for a significantly higher percentage of smokers in the ra nitidine group. The percentage of total healing was almost the same wi th both products. Healing occurred in a higher percentage with ebrotid ine at weeks 4 (75% versus 66.7%) and 6 (87% Versus 79.7%). A higher e ffect of ebrotidine on the incidence of duodenitis was identified duri ng the whole study, but only reached statistical significance at week 6. The relapse rate during the follow-up phase showed no differences b etween the two study treatments, relapse percentage figures being 25% for ebrotidine and 24% for ranitidine. There were no differences in th e number of unscheduled visits between the two groups, although 57% of patients in the ranitidine group had to make a second follow-up visit , as compared with 33% in the ebrotidine group. Both drugs caused hard ly any side effects, affecting only one patient from each group: one p atient with ebrotidine suffered from diarrhoea and one patient with ra nitidine developed a skin rash on the limbs. Administration of ebrotid ine in a single dose (400 mg/d) was at least as effective and safe as ranitidine both for healing and relapse prevention in patients with du odenal ulcer.