A double-blind, short-term clinical trial of pirenzepine in duodenal ulcer. 1979

A Morelli, and F Narducci, and M A Pelli, and A Spadacini

The effectiveness of pirenzepine in the treatment of duodenal ulcer was assessed in a double-blind clinical trial in comparison with placebo. Twenty-nine of 30 patients satisfactorily completed the trial. There was endoscopic ulcer healing in 4 of 14 pirenzepine treated patients (29%) after 2 weeks of treatment and in 11 of 14 (79%) after 6 weeks. There was no healing in 15 patients treated with placebo after 2 weeks and there were two ulcers healed after 6 weeks. The difference between pirenzepine and placebo was significant in both 2nd and 6th week. Duodenitis (evaluated by endoscopy) markedly improved in the pirenzepine grouu after 2 (4 of 9 patients) and after 6 weeks of treatment (8 of 9), while no, or only slight, improvement was observed in 8 of 8 patients in the placebo group. When evaluated by ulcer symptom relief and antacid tablet comsumption, pirenzepine proved to be considerable more efficacious than the placebo. The results of this study demonstrate that pirenzepine promoted duodenal ulcer healing, that it markedly improved peptic duodenitis and promoted rapid regression of symptomatology in parallel with endoscopic findings.

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
D004382 Duodenitis Inflammation of the DUODENUM section of the small intestine (INTESTINE, SMALL). Erosive duodenitis may cause bleeding in the UPPER GI TRACT and PEPTIC ULCER. Erosive Duodenitis,Duodenitis, Erosive

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