COMPARISON OF ONCE-DAILY DOSES OF OMEPRAZOLE (40 AND 20 MG) AND PLACEBO IN THE TREATMENT OF BENIGN GASTRIC-ULCER - A MULTICENTER, RANDOMIZED, DOUBLE-BLIND-STUDY

Objective: The purpose of this multicenter, randomized, double-blind;s tudy, conducted in 520 patients, was to compare the efficacy and safet y of omeprazole (40 and 20 mg once daily) with placebo in the treatmen t of benign gastric ulcer. Methods: Treatment with omeprazole or place bo lasted 4 wk; those whose ulcers remained unhealed continued the sam e treatment regimen for an additional 4 wk. The effects of therapy wer e determined by endoscopy and assessment of GI symptoms. Safety and to lerability were evaluated through reported adverse events, physical ex aminations, and laboratory tests. Results: At weeks 4 and 8, the propo rtion of patients with healed ulcers was significantly greater in the omeprazole 40- and 20-mg groups than in the placebo group (p < 0.01). At week 8, the healing rate was significantly greater in the 40-mg gro up than in the 20-mg group (82.7 vs 74.8%, p < 0.05). In patients with large ulcers (>1 cm), the 40-mg regimen was associated with a signifi cantly higher healing rate (78.9%) than both the 20-mg regimen (61.4%) and placebo (34.6%) at week 8 (p < 0.05 vs omeprazole 20 mg; p < 0.01 vs placebo). Healing rates in patients with small ulcers were similar for the 40- and 20-mg groups. Omeprazole was well tolerated, with no significant differences versus placebo in the overall incidence of cli nical or laboratory adverse events. Conclusions: Omeprazole 40 and 20 mg, administered once daily, healed a significantly greater proportion of patients than did placebo. The 40-mg regimen offered significant a dvantages over the 20-mg regimen in patients with large ulcers.