Pirenzepine in the treatment of duodenal ulcer. 1979

N D'Imperio, and G Giuliani Piccari, and A M Lepore, and F Sarti, and P R Dal Monte

The effectiveness and safety of pirenzepine (PRZ) at 150 mg daily in the treatment of active duodenal ulcer was studied in an open pilot clinical trial followed by a double-blind trial against placebo. The open pilot study showed that pirenzepine was well tolerated and promoted ulcer healing in the 45% of patients within 2 weeks of treatment and in 90% within 4 weeks. The double-blind trial against placebo (PL) Confirmed these results: 60% of the patients in PRZ group and 10% of the patients in PL group showed endoscopic ulcer healing after 2 weeks. This difference was significant. Ninety per cent of the PRZ patients and 50% of the PL patients were completely healed after 4 weeks. In the PRZ group, gastric secretory tests showed a significant decrease in B.A.O. (69%), M.A.O. (33%) and P.A.O. (34%) after 2 weeks. In the PL group, the same parameters had only a small decrease, without statistical significance. There were no pathological changes in laboratory findings in either the open or the double-blind studies. Mild and transient side-effects were observed in 7 of 30 patinets receiving pirenzepine (diplopia and dryness of the mouth).

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010879 Piperazines Compounds that are derived from PIPERAZINE.
D010890 Pirenzepine An antimuscarinic agent that inhibits gastric secretion at lower doses than are required to affect gastrointestinal motility, salivary, central nervous system, cardiovascular, ocular, and urinary function. It promotes the healing of duodenal ulcers and due to its cytoprotective action is beneficial in the prevention of duodenal ulcer recurrence. It also potentiates the effect of other antiulcer agents such as CIMETIDINE and RANITIDINE. It is generally well tolerated by patients. Gastrotsepin,Gastrozepin,L-S 519,LS-519,Piren-Basan,Pirenzepin,Pirenzepin Von Ct,Pirenzepin-Ratiopharm,Pirenzepine Dihydrochloride,Pyrenzepine,Ulcoprotect,Ulgescum,Dihydrochloride, Pirenzepine,LS 519,LS519,Piren Basan,Pirenzepin Ratiopharm,Von Ct, Pirenzepin
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004381 Duodenal Ulcer A PEPTIC ULCER located in the DUODENUM. Curling's Ulcer,Curling Ulcer,Curlings Ulcer,Duodenal Ulcers,Ulcer, Curling,Ulcer, Duodenal,Ulcers, Duodenal
D005260 Female Females

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