Nocturnal dosage regimen of sucralfate in maintenance treatment of gastric ulcer.

Sixty-six patients with recently healed gastric ulcers were entered into a double-blind, placebo-controlled, six-month maintenance trial to determine whether sucralfate 2 g at night reduces the liability to recurrent ulceration. Thirty-three patients were randomly assigned to treatment with sucralfate and 33 were assigned to placebo. Endoscopy was performed at the time of entry into the study and at 24 weeks, or earlier if clinical relapse occurred during this period. Of the patients available for analysis, endoscopic recurrences were found in eight of the 29 patients (28 percent) randomly assigned to sucralfate and in 15 of the 27 patients (56 percent) assigned to placebo. Eight of the recurrences noted at 24 weeks were asymptomatic and, of these, five were in the placebo-treated group. The cumulative relapse rate at 24 weeks was significantly lower in the sucralfate-treated group (p less than 0.05), and the Cox-Mantel text showed a significant difference between the cumulative relapse curves of the two treatment groups over the 24-week period (p less than 0.05). The results indicate that a single maintenance dose of sucralfate 2 g at night reduces the relapse rate in patients with recently healed gastric ulceration.