NIZATIDINE VERSUS PLACEBO IN GASTROESOPHAGEAL REFLUX DISEASE - A 6-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARISON (REPRINTED FROM DIGESTIVE DISEASES AND SCIENCES, VOL 37, PG 865, 1992)

In a randomised, multicentre trial, nizatidine 150 mg or 300 mg or pla cebo was administered twice daily for 6 weeks to 515 patients with gas tro-oesophageal reflux disease (GORD). Antacid tablets were taken as n eeded for pain. Significantly superior rates of endoscopically proven complete healing (normal-appearing mucosa) versus placebo occurred aft er 3 weeks with nizatidine 150 mg and after 6 weeks with nizatidine 30 0 mg. Six-week healing rates were 38.5% for nizatidine 300 mg, 41.1% f or nizatidine 150 mg, and 25.8% for placebo. The nizatidine 150 mg tre atment group had significantly greater improvement in daytime and nigh ttime heartburn severity after 1 day of therapy versus placebo. Twice- daily administration of nizatidine 150 mg or 300 mg provides prompt re lief from the major symptom of GORD, heartburn, and complete healing o f oesophagitis is seen in many patients.