EFFICACY OF EBROTIDINE AND RANITIDINE COMBINED WITH AMOXICILLIN AND METRONIDAZOLE IN THE ERADICATION OF HELICOBACTER-PYLORI IN PATIENTS WITH DUODENAL-ULCER

This double-blind, randomized, phase III clinical trial was carried ou t in two parallel groups to assess the efficacy of ebrotidine ethyl]am ino]methylene]-4-bromo-benzenesulfonamide, CAS 100981-43-9, FI-3542) 4 00 mg and ranitidine 300 mg given in single evening dose, combined wit h amoxicillin 750 mg and metronidazole 500 mg three times daily for 14 days, in the eradication of Helicobacter pylori in patients with duod enal ulcer. Thirty patients were included, divided into two groups of 15, to whom one of the study therapies was administered based on a ran domization code. Clinical and endoscopic controls were performed 4, 6 and 8 weeks after the onset of the treatment. No differences were seen between the two treatment groups with regard to demographic parameter s and clinical histories. They were both perfectly homogeneous. There were no differences between the eradication of both therapies in both the antrum and gastric body samples (over 80% eradication), allowing t he results to be classified as satisfactory. Moreover, perfect control was achieved through the study of clinical symptoms, which even disap peared in some cases. There were no differences in the healing rate of the duodenal ulcer after four weeks, 86.7% being achieved for both gr oups.