Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02620696
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2015-12-01
Brief Title:
Effect of Netazepide on Omeprazole-induced Changes in Chromogranin A and Gastrin
Sponsor:
Trio Medicines Ltd
Organization:
Trio Medicines Ltd
Study Overview
Official Title:
Effect of Netazepide a GastrinCCK2 Receptor Antagonist on Esomeprazole-induced Increases in Circulating Gastrin and Chromogranin A and on Esomeprazole Withdrawal in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 gastrinCCK2 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
The objective of the study was to determine the dosage regimen of netazepide a gastrinCCK2 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
Detailed Description:
Non-clinical studies have shown that PPI-induced hypergastrinaemia leads to rebound gastric hyperacidity after PPI withdrawal A gastrinCCK2 receptor antagonist inhibits that response Studies in healthy subjects and patients also suggest that PPI withdrawal leads to rebound hyperacidity but the evidence is controversial However there is better evidence from studies in healthy subjects that PPI withdrawal can lead to dyspepsia
The principal aims of this study were to assess the effect of different dose regimens of netazepide on the increases in circulating gastrin and CgA induced by esomeprazole in healthy subjects and to choose a dose regimen for future studies of esomeprazole withdrawal in patients The secondary aims were to assess if omeprazole withdrawal leads to dyspepsia and if so whether it can be prevented by netazepide and to assess the likelihood of an interaction between esomeprazole and netazepide Gastrin and CgA are biomarkers of acid suppression and increased ECL-cell activity respectively
This was a randomised double-blind placebo-controlled parallel-group pilot study in which six groups of eight healthy subjects took 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 the 14 days immediately following esomeprazole withdrawal 25 mg only Gastrin and CgA were measured before the start of dosing until at least one week after completion of dosing
The principal aims of this study were to assess the effect of different dose regimens of netazepide on the increases in circulating gastrin and CgA induced by esomeprazole in healthy subjects and to choose a dose regimen for future studies of esomeprazole withdrawal in patients The secondary aims were to assess if omeprazole withdrawal leads to dyspepsia and if so whether it can be prevented by netazepide and to assess the likelihood of an interaction between esomeprazole and netazepide Gastrin and CgA are biomarkers of acid suppression and increased ECL-cell activity respectively
This was a randomised double-blind placebo-controlled parallel-group pilot study in which six groups of eight healthy subjects took 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 the 14 days immediately following esomeprazole withdrawal 25 mg only Gastrin and CgA were measured before the start of dosing until at least one week after completion of dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None