RESUMO
One hundred and seventy three patients suffering from duodenal ulcer, were selected for a double-blind, controlled and randomized parallel multicenter study, with interval endoscopic examinations. This study was undertaken to compare the efficacy and safety of nizatidine administered at a single dose (300 mg "nocte") versus ranitidine (300 mg "nocte") in the treatment of acute duodenal ulcer. One hundred and sixty five patients were found to meet every admission criterion and completed the study (86 on nizatidine and 79 on ranitidine). On admission to the study, both groups were seen to have been correctly selected and epidemiologically well-distributed as to history of duodenal ulcer, previous treatments and pre-study symptoms. The ulcer was considered healed when complete re-epithelialization had occurred in areas of ulcerated mucosa. Healing rates of duodenal ulcer proved to be globally similar in the two groups, both in the 4th week (nizatidine, 78%; ranitidine, 78%) and in the 8th week (nizatidine, 91%; ranitidine, 95%). After four weeks of treatment, 67% of the patients treated with nizatidine no longer had any symptoms, while 87% patients no longer suffered from day pain, and 91% had no nocturnal pain. As a result, intake of antacids quickly decreased during the first four weeks. A similar response was observed in the group receiving ranitidine. After administration at a single dose of 300 mg in the evening, nizatidine proved to be at least as effective and safe as 300 mg of ranitidine administered in the same way, with respect both to ulcer healing and symptom response.