EBROTIDINE VERSUS RANITIDINE IN THE TREATMENT OF ACUTE DUODENAL-ULCER- A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED CLINICAL-TRIAL

A total of 478 patients with endoscopically confirmed duodenal ulcer e ntered this randomized, parallel, double-blind trial. Patients were ra ndomly assigned to receive ebrotidine ethyl]amino]methylene]-4-bromo-b enzenesulfonamide, CAS 100981-43-9, F1-3542) 400 mg or ranitidine 300 mg tablets (4:1) respectively, administered in single evening doses. E ndoscopy, clinical examination and symptom assessment were performed a t baseline and at weeks 4 and 8. Safety evaluations including laborato ry tests, treatment compliance and antacid consumption checks were con ducted at the beginning and/or at the 4 and 8 week visits. Patients wh ose ulcer showed endoscopic healing at the 4-week control left the stu dy. Both groups were matched in all parameters studied. The healing ra tes at 4 weeks were 76.4% and 75.3% for ebrotidine and ranitidine resp ectively, while at 8 weeks the final rates were 95% and 91.8% respecti vely. Accompanying symptoms disappeared rapidly and the patients retur ned to normal. Smoking proved to be a highly significant negative risk factor, since healing rates were 83.4% and 71.2% at 4 weeks and 97.4% and 92.3% at 8 weeks in non-smokers and smokers respectively (p = 0.0 046). Smokers treated with ranitidine showed significantly lower final healing rates than non-smokers (86% vs 100%; p = 0.0358), while the h ealing rates among patients treated with ebrotidine were similar regar dless of whether they were smokers or not (93.9% and 96.7% N.S.). Ebro tidine (94%) proved to be more effective than ranitidine (86%) in smok ers with higher healing rates (p < 0.05). Alcohol intake showed no sig nificant relationship with the healing rates. Both drugs demonstrated an excellent safety. There were no changes in blood parameters, and no significant adverse events were reported.