Controlled double-blind study of the therapeutic effect of pirenzepine dihydrochloride in duodenal ulcer. Phase III study.
A controlled double-blind study was performed in 17 institutes using gefarnate as a control drug in order to investigate the therapeutic effect and safety of pirenzepine dihydrochloride (LS 519) in duodenal ulcer. A total of 233 subjects were studied, 110 in the pirenzepine group (LS group) and 123 in the gefarnate group (GF group). Final improvement rate of ulcer lesions (8 weeks) of LS group showed the highly significant superiority over the GF group. Cumulative healing rates based on endoscopic findings of 17.9, 49.4, 67.0, 84.2 and 91.2% were found for the LS group at the 2nd, 4th, 6th, 8th, 10th and 12th weeks, respectively; the respective values for the GF group being 14.7, 33.0, 51.5, 66.7, 70.5 and 72.4%. Thus, the LS group showed a significantly superior acceleration of healing to that of the GF group on all occasions but the 2nd week. The improvement rate of subjective symptoms for moderately and markedly improved cases together totalled 98.9% for the LS group and 81.2% for the GF group, indicating the significant superiority of the former. These results proved the excellent therapeutic effect of pirenzepine. No significant difference in safety was found between the two drug groups. Gastric analysis was carried out before the start of drug administration and of its termination. In the healed subjects treated with pirenzepine there were a significant decrease in the secretion volume and acid output, and also a tendency to decrease in the acidity in basal secretion; and further a tendency to decrease in the acidity in maximally stimulated secretion.
D001570:Benzodiazepinones / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D010890:Pirenzepine; D011897:Random Allocation
D001570:Benzodiazepinones; D010890:Pirenzepine