title: A double-blind, randomized, dose response study testing the pharmacological efficacy of synthetic porcine secretin.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors: Duke University Medical Center, Durham, NC, USA. Paul.Jowell@duke.edu
authors: P S
authors: PS
authors: Jowell
authors: G
authors: G
authors: Robuck-Mangum
authors: K
authors: K
authors: Mergener
authors: M S
authors: MS
authors: Branch
authors: E D
authors: ED
authors: Purich
authors: S H
authors: SH
authors: Fein
mesh_terms: D000328:Adult; D000818:Animals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012633:Secretin / Q000009:adverse effects / Q000494:pharmacology*; D013552:Swine
chemical_list: D012633:Secretin