[Dose finding study of telenzepine (1.5 vs. 3 vs 5 mg once daily) in acute treatment of duodenal ulcer. A double-blind, randomized, multicenter parallel group comparison].
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.
Hüttemann
W
W
Schneider
A
A
D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010276:Parasympatholytics / Q000008:administration & dosage*; D010890:Pirenzepine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016032:Randomized Controlled Trials as Topic
D010276:Parasympatholytics; C046338:telenzepine; D010890:Pirenzepine
Dosisfindungsstudie von Telenzepin (1.5 vs. 3 vs. 5 mg, einmal täglich) in der Akuttherapie des Ulcus duodeni. Ein doppelblinder, randomisierter, multizentrischer Parallelgruppenvergleich.