OBJECTIVES: A multicenter, double-blind study was conducted in 268 patients to compare the safety and efficacy of 15, 30, and 60 mg of lansoprazole and placebo in the treatment of gastric ulcer. METHODS: The study included an 8-wk treatment period to assess healing and a 6-month posttreatment period to evaluate ulcer recurrence. Endoscopies were performed, GI symptoms and antacid use were assessed, and safety evaluations were conducted, including serum gastrin and biopsies of the lesions and the greater curvature of the stomach. RESULTS: At week 4, healing rates were significantly higher with lansoprazole 15 and 30 mg (64.6 and 58.1%, respectively) compared with placebo (37.5%). By week 8, healing rates were 76.7% with placebo, 92.2% with 15 mg of lansoprazole, 96.8% with 30 mg, and 93.2% with 60 mg of lansoprazole (p < 0.05). The drug was well tolerated, with no significant differences from placebo in the incidence of adverse events. Fasting serum gastrin increased in all lansoprazole groups, reaching a plateau by week 2 and returning to baseline levels by month 1 posttreatment. No significant increase in Grimelius-positive cells or inflammation was evident. All but two patients had normal gastric morphology evaluated by Solcia classification. CONCLUSIONS:Lansoprazole, 15, 30, and 60 mg, administered once daily before eating, healed gastric ulcers to an approximately equal degree, and all were significantly better than placebo.
RCT Entities:
OBJECTIVES: A multicenter, double-blind study was conducted in 268 patients to compare the safety and efficacy of 15, 30, and 60 mg of lansoprazole and placebo in the treatment of gastric ulcer. METHODS: The study included an 8-wk treatment period to assess healing and a 6-month posttreatment period to evaluate ulcer recurrence. Endoscopies were performed, GI symptoms and antacid use were assessed, and safety evaluations were conducted, including serum gastrin and biopsies of the lesions and the greater curvature of the stomach. RESULTS: At week 4, healing rates were significantly higher with lansoprazole 15 and 30 mg (64.6 and 58.1%, respectively) compared with placebo (37.5%). By week 8, healing rates were 76.7% with placebo, 92.2% with 15 mg of lansoprazole, 96.8% with 30 mg, and 93.2% with 60 mg of lansoprazole (p < 0.05). The drug was well tolerated, with no significant differences from placebo in the incidence of adverse events. Fasting serum gastrin increased in all lansoprazole groups, reaching a plateau by week 2 and returning to baseline levels by month 1 posttreatment. No significant increase in Grimelius-positive cells or inflammation was evident. All but two patients had normal gastric morphology evaluated by Solcia classification. CONCLUSIONS:Lansoprazole, 15, 30, and 60 mg, administered once daily before eating, healed gastric ulcers to an approximately equal degree, and all were significantly better than placebo.