Bentiromide as a test of exocrine pancreatic function in adult patients with pancreatic exocrine insufficiency. Determination of appropriate dose and urinary collection interval.

A dose-ranging crossover study of orally administered bentiromide was conducted in 47 patients with chronic pancreatic disease and 61 healthy volunteers. Four doses (100 mg, 500 mg, 1 g, and 5 g) and postdosing urine collection periods (0-3, 0-6, 0-12, and 0-24 h) were studied. Of these, the 500-mg dose and 0-6-h urine collection period afforded maximal separation of urinary arylamine excretion rates between the two populations. At this dose and collection period, the lower limit of normal (mean - 2 SD) for the control group was 57%; none of the healthy volunteers had 6-h arylamine excretion rates less than 50%. The agent was well tolerated except at the 5-g dose level, where nausea, vomiting, and diarrhea were common. Bentiromide appears to be a useful agent in the assessment of exocrine pancreatic function.

RCT Entities:   Population Interventions Outcomes