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Healing and recurrence of active duodenal ulcer with nizatidine
Author(s) -
Cloud Michelle L,
Offen Walter W,
Matsumoto Charles,
Chernish Stanley M
Publication year - 1989
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.1989.144
Subject(s) - placebo , medicine , gastroenterology , clinical trial , phases of clinical research , duodenal ulcer , clinical pharmacology , surgery , pharmacology , pathology , alternative medicine
Nizatidine, a new H 2 ‐receptor antagonist for treatment of duodenal ulcer disease, was evaluated in a unique two‐phase, placebo‐controlled, randomized, double‐blind, multicenter clinical trial. Patients received either 150 mg nizatidine twice daily or placebo for 4 weeks (phase I). If ulcer healing did not occur during phase I, patients were randomly reallocated to receive either 150 mg nizatidine twice daily or placebo for an additional 4 weeks (phase II). Patients with a healed ulcer continued on the same therapy. All patients were endoscoped at week 8. Healing rates at week 2 were 93 of 265 (35%) nizatidine‐treated patients and 55 of 260 (21%) placebo‐treated patients ( p < 0.001); at week 4, healing rates were 198 of 259 (76%) nizatidine‐treated patients and 95 of 243 (39%) placebo‐treated patients ( p < 0.001). In phase II, ulcer healing occurred in 46 of 86 (53%) nizatidine‐treated patients and in 23 of 90 (26%) placebo‐treated patients ( p = 0.002). In patients who had a healed ulcer at previous endoscopies, 18 of 178 (10%) nizatidine‐treated patients and 10 of 81 (12%) placebo‐treated patients had a recurrence of duodenal ulcer. Smokers who had histories of previous ulcers were more likely to have an early recurrence. Clinical Pharmacology and Therapeutics (1989) 46 , 310–316; doi: 10.1038/clpt.1989.144