Effect of Netazepide on Omeprazole-induced Changes in Chromogranin A and Gastrin
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
Hypergastrinaemia induced by proton pump inhibitor (PPI) treatment is reported to cause
ECL-cell and parietal-cell hyperplasia, and rebound hyperacidity and dyspepsia after PPI
withdrawal.
The objective of the study was to determine the dosage regimen of netazepide, a gastrin/CCK2
receptor antagonist, required to inhibit the trophic effects of PPI-induced
hypergastrinaemia.
Six groups of 8 healthy subjects participated in a randomised, double-blind,
placebo-controlled exploratory study of esomeprazole 40 mg daily for 28 days, and netazepide
1, 5 or 25 mg, or placebo daily during the last 14 days of esomeprazole dosing, or 14 days
after esomeprazole withdrawal. Serum gastrin and plasma chromogranin A (CgA) were measured
regularly from study start until at least 1 week after the last dose. Dyspepsia was monitored
after esomeprazole withdrawal.