Three different doses of the M1-selective
antimuscarinic compound
telenzepine were investigated in the treatment of acute
duodenal ulcer in a randomized, double-blind dose-range finding study. In four investigating centers, 120 patients with endoscopically proven, florid
duodenal ulcer were treated with either 1.5 mg, 3 mg or 5 mg
telenzepine once daily at bedtime (40 patients per dose group). After two weeks of treatment differences in the healing rates were statistically not significant. After four weeks the
ulcers of 26 (65%) patients in the 1.5 mg group and 34 (85%) and 31 (78%) in the 3 mg and 5 mg groups, respectively, were completely healed. Only the difference in the healing rates between the 1.5 and 3 mg groups was significant at p less than 0.05. Mean reductions in
ulcer area were 90% (1.5 mg), 97% (3 mg) and 93% (5 mg) after four weeks; 1.5 vs. 3 mg, p less than 0.025. These results show that
telenzepine dose-dependently accelerates
ulcer healing and that maximal effect is obtained with the 3-mg dose. The
ulcer symptoms were dose-dependently alleviated. Dry mouth of moderate or severe intensity was stated more frequently under 5 mg
telenzepine (by 14% of patients) than under 1.5 and 3 mg (5% each). The
antimuscarinic side effect "disturbed accommodation" was rarely found. It is concluded that once daily administration of 3 mg in the evening must be regarded as the optimal dosage regimen of
telenzepine.