Nizatidine versus placebo in gastro-oesophageal reflux disease: a 6-week, multicentre, randomised, double-blind comparison. Nizatidine Gastroesophageal Reflux Disease Study Group.
In a randomised, multicentre trial, nizatidine 150 mg or 300 mg or placebo was administered twice daily for 6 weeks to 515 patients with gastro-oesophageal reflux disease (GORD). Antacid tablets were taken as needed for pain. Significantly superior rates of endoscopically proven complete healing (normal-appearing mucosa) versus placebo occurred after 3 weeks with nizatidine 150 mg and after 6 weeks with nizatidine 300 mg. Six-week healing rates were 38.5% for nizatidine 300 mg, 41.1% for nizatidine 150 mg, and 25.8% for placebo. The nizatidine 150 mg treatment group had significantly greater improvement in daytime and nighttime heartburn severity after 1 day of therapy versus placebo. Twice-daily administration of nizatidine 150 mg or 300 mg provides prompt relief from the major symptom of GORD, heartburn, and complete healing of oesophagitis is seen in many patients.
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Lilly Research Laboratories, Eli Lilly & Co, Indianapolis, Indiana 46285, USA.
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D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004941:Esophagitis / Q000188:drug therapy; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016567:Nizatidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D016567:Nizatidine