Healing and recurrence of active duodenal ulcer with nizatidine

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