Twice-daily sucralfate dosing to heal acute duodenal ulcer. Multicenter Study Group

Twice-daily dosing with sucralfate was evaluated by two multicenter trials, trial 1 (eight weeks) and trial 2 (four weeks). Both trials demonstrated significantly better ulcer healing at study completion for the 2-g twice daily (B.I.D.) regimen compared with placebo. Both trials were double-blind, randomized, and placebo-controlled, with parallel groups. Patients received two doses daily consisting of sucralfate 2 g B.I.D., placebo/sucralfate 2 g at bedtime (H.S.), or placebo/placebo. Ulcer healing was assessed by scheduled endoscopy and symptom assessment. Healing was defined as complete absence of erosion or ulceration. Trial 1 evaluations were conducted at four and eight weeks, trial 2 evaluations at two and four weeks. Interim examinations were performed at investigator discretion. Treatment groups were comparable with regard to number of patients, age, sex, smoking status, ulcer size, and presence/absence of baseline symptoms. Sucralfate 2 g B.I.D. was significantly better than H.S. or placebo dosing at the completion of each trial. H.S. dosing was better than placebo only at the four-week analysis of trial 1. At Week 4 of trial 1, 14 of 54 patients (26 percent) were healed with the B.I.D. sucralfate regimen, whereas at Week 8, 41 of 54 (76 percent) were healed (p less than 0.001). For the placebo/sucralfate H.S. group, 17 of 57 patients (30 percent) were healed at Week 4 (p less than 0.05), and 32 of 56 patients (57 percent) were healed at Week 8. For the placebo group, six of 52 (12 percent) and 20 of 51 patients (39 percent) were healed at Weeks 4 and 8, respectively. In trial 2, the B.I.D. group had a 21 percent healing rate at Week 2 (13 of 61 patients) and 62 percent were healed at Week 4 (38 of 61 patients; p less than 0.05). The H.S. group had an 8 percent healing rate (five of 66 patients) at Week 2 and 50 percent (33 of 66 patients) at Week 4. For the placebo group, 10 of 62 patients (16 percent) and 26 of 62 patients (42 percent) were healed at Weeks 2 and 4, respectively. Trial 1 demonstrated significant symptom improvement for active treatment groups at both four and eight weeks, whereas no differences were found in trial 2. Sucralfate 2 g B.I.D. was found to be safe and effective for the treatment of acute duodenal ulcer.