A double-blind, randomized, dose response study testing the pharmacological efficacy of synthetic porcine secretin.
(Clinical Trial;Journal Article)
BACKGROUND: Biologically derived porcine secretin has been used as a diagnostic agent in clinical gastrointestinal practice for many years. Pure synthetic porcine secretin is now available for investigational clinical use. AIM: To compare the pharmacology of synthetic porcine secretin and biologically derived porcine secretin in healthy volunteers. METHODS: Secretin stimulation tests were performed in 12 volunteer subjects in a double-blind, randomized, Latin square crossover design study comparing three doses of synthetic porcine secretin (0.05, 0.2, and 0.4 microgram/kg) with a standard dose of biologically derived porcine secretin (1 CU/kg). Duodenal aspirates were analysed for total volume and for bicarbonate concentration. Total bicarbonate output was calculated. RESULTS: Twelve subjects completed four dosing regimens. A multiple comparison test was used to compare dosing regimens. The 0.2 and 0.4 microgram/kg doses of synthetic porcine secretin were not different from the 1 CU/kg dose of biologically derived porcine secretin for volume, bicarbonate concentration and total output from 0 to 60 min. Only one patient had an adverse event, which was mild, transient flushing after the 0.2 and 0.4 microgram/kg doses of synthetic porcine secretin and after the 1 CU/kg dose of biologically derived porcine secretin. CONCLUSIONS: Synthetic porcine secretin has identical pharmacologic effects to biologically derived porcine secretin in normal subjects. Both drugs were safe and well-tolerated. This study validates synthetic porcine secretin as a substitute for biologically derived porcine secretin.
Jowell, PS; Robuck-Mangum, G; Mergener, K; Branch, MS; Purich, ED; Fein, SH
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