PIRENZEPINE (LS 519) IN SEVERE DUODENAL ULCER AND IN GASTRIC ULCER. A DUBLE-BLIND CLINICAL TRIAL

Abstract Duodenal ulcer. Forty-five of 49 adult outpatients with active, severe, endoscopically proven duodenal ulcers completed a 4-week double-blind trial comparing two doses of LS 519 (75 and 150 mg/day) with placebo. After 2 weeks, 1 of 15 patients given LS 75 mg and 4 of 15 given LS 150 mg/day had healed (P = 0.09). No patient given placebo had healed. After 4 weeks, 6 of 15 (40%) on placebo, 9 of 15 (60%) on LS 75 mg and 13 of 15 (86.7%) on LS 153 mg had healed (P less than 0.01). Patients given the highest dose of LS had significantly more pain-free days and nights and took fewer antacid tablets than those receiving the lowest dose of LS or placebo. Gastric ulcer. 19 of 20 adult outpatients with endoscopically proven active benign gastric ulcers completed a double-blind 4-week trial with either LS 519 (75 mg/day) or carbenoxolone (300 mg/day). Six of 10 (60%) given LS and 6 of 9 (66.7%) given carbenoxolone had healed after 4 weeks (N.S.). Symptomatic improvement was significantly faster in the LS group than in the carbenoxolone group. Hypokaliemia, increases in alkaline phosphatase and SGOT were observed in the carbenoxolone group.