triprolidine and Duodenal-Ulcer

Clinical trials often identify two endpoints or response measures of interest. Depending on the drugs and the disease, the endpoints may be correlated or uncorrelated, reflect efficacy or safety, or one or both may be considered as primary. For visualization, plots of each endpoint from baseline to the end of the trial are presented for each treatment group. This paper illustrates the usefulness of developing bivariate, composite plots of both endpoints jointly. Two applications are presented: one of a fixed combination drug for treating allergic rhinitis, and the other of a dose comparison trial in duodenal ulcer.

Topics: Airway Resistance; Anti-Allergic Agents; Anti-Ulcer Agents; Cimetidine; Clinical Trials as Topic; Data Interpretation, Statistical; Dose-Response Relationship, Drug; Drug Combinations; Duodenal Ulcer; Endpoint Determination; Humans; Nasal Decongestants; Pseudoephedrine; Randomized Controlled Trials as Topic; Rhinitis, Allergic, Seasonal; Triprolidine

An inhibitor of gastric secretion, Pfizer UK -9040, a derivative of the antihistamine triprolidine, was given orally 50 to 100 mg per kg 1 hr before and at various times during a 24-hr subcutanwous infusion of ulcerogenic secretagogues. The higher the dose and the more frequent the dosage, the lower was the incidence, severity, number, and perforations of duodenal ulcers. The mechanisms by which UK -9040 prevents these ulcers is probably inhibition of gastric secretion.

Topics: Animals; Carbachol; Dose-Response Relationship, Drug; Duodenal Ulcer; Gastric Juice; Histamine; Male; Pentagastrin; Peptic Ulcer Perforation; Pyridines; Rats; Stimulation, Chemical; Triprolidine