Nizatidine versus placebo in active benign gastric ulcer disease: An eight-week, multicenter, randomized, double-blind comparison

Autor: Nathan Enas, Michelle L. Cloud, Walter W. Offen
Rok vydání: 1992
Předmět:
Zdroj: Clinical Pharmacology and Therapeutics. 52:307-313
ISSN: 1532-6535
0009-9236
DOI: 10.1038/clpt.1992.146
Popis: Study objective: To determine if 150 mg nizatidine twice daily or 300 mg nizatidine at bedtime are similarly effective and to compare each dose with placebo in healing benign gastric ulcers and relieving peptic ulcer symptoms. Methods: This study was a randomized, double-blind, placebo-controlled parallel comparison. The study was conducted at 74 gastroenterology and internal medicine clinics in the United States and Canada. Four hundred fifty-six patients with active benign gastric ulcer documented by endoscopy participated in the study. On the basis of a computer-generated randomization list, patients were assigned sequentially to receive either 150 mg nizatidine twice daily (n = 151), 300 mg nizatidine once daily at bedtime and identically appearing placebo capsules in the morning (n = 153), or placebo capsules twice daily (n = 152). Treatment lasted for 8 weeks unless healing was documented by endoscopy after 4 weeks. Antacid tablets (aluminum hydroxide, magnesium hydroxide, simethicone combination) were supplied for relief of symptoms. Measurements and main results: Both doses of nizatidine significantly improved healing rates at 8 weeks compared with placebo. Daytime and nighttime symptom severity was improved by both nizatidine regimens at end point (p < 0.015 versus placebo, two-tailed test). Antacid use was similar for all groups in the end point analysis. Patient well-being was significantly better in patients treated with nizatidine than in patients in the placebo group ((p < 0.04, two-tailed test). No clinically significant differences in the incidence of adverse clinical or laboratory events were noted. Conclusion: Nizatidine, 300 mg at bedtime and 150 mg twice daily, resulted in greater healing of benign gastric ulcers than placebo treatment after 8 weeks. Relief of the symptoms of gastric ulcer was significantly better in the patients receiving nizatidine treatment versus placebo treatment. Clinical Pharmacology and Therapeutics (1992) 52, 307–313; doi:10.1038/clpt.1992.146
Databáze: OpenAIRE
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