EFFICACY OF EBROTIDINE AND RANITIDINE IN THE TREATMENT OF BENIGN GASTRIC-ULCER

This is a phase III, randomized, double-blind, clinical trial with two parallel groups of 50 patients to assess the efficacy of ebrotidine ] ethyl]amino]methylene]-4-bromo-benzenesulfonamide CAS 100981-43-9, FI- 3542) 800 mg and ranitidine 300 mg as a single evening dose in the tre atment of benign gastric peptic ulcer. Prior to treatment, an endoscop y was performed to detect ulcer lesions and to discard malignancies. C linical and endoscopic examinations were performed at 6, 9 and 12 week s. Healing rates were significant for both treatments at week 6, while at week 12 there was statistical significance for ebrotidine as compa red to ranitidine (96% vs 88% in the intention-to-treat analysis and 9 8% vs 87.5% in the per protocol analysis). Decrease in ulcer diameter was significant for both treatments at week 6, and for ebrotidine vers us ranitidine at weeks 9 and 12. The overall improvement of symptoms w as higher with ebrotidine, which was already significant at week 6. Sa fety was considered to be excellent, since no significant adverse even ts were reported for the patients included in the study.