Double blind controlled trial with oxmetidine and cimetidine in the short-term treatment of duodenal ulcer.

Clinical efficacy and safety of oxmetidine (400 mg b.i.d.), a new potent specific H2-receptor antagonist, and cimetidine (1 g/day) were compared in a double-blind randomized trial of 4 weeks duration that involved 39 outpatients with endoscopically proven active duodenal ulcer. The disappearance of the ulcer crater leading to complete reepithelization of the bulbs or to the presence of erosions occurred in 17 out of 19 (89.6%) patients treated with oxmetidine, and in 13 out of 20 (65.0%) patients treated with cimetidine (n.s.). Ulcer symptoms and antacid consumption were not different in two groups. No side effects or significant haematological or biochemical abnormalities were found. Both drugs failed to evoke significant changes in the basal levels of prolactin (PRL) and gonadotropins. The higher, though not significant, percentage of healing obtained with oxmetidine had no clinical relevance and needs to be demonstrated in a larger number of patients.