Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02476097
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-26
First Post:
2015-06-15
Brief Title:
PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms
Sponsor:
Victoria Rollason
Organization:
University Hospital Geneva
Study Overview
Official Title:
Study of the Effect of PROGRESSive Withdrawal Esomeprazole of on Acid-related Symptoms PROGRESS Study A Randomized Placebo-controlled Double Blinded Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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:
PROGRESS
Brief Summary:
Rebound acid hypersecretion RAHS defined as an increase in gastric acid secretion above pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of treatment and could theoretically lead to acid-related symptoms such as heartburn acid regurgitation or dyspepsia that might result in resumption of therapy A plausible physiologic theory for the rebound phenomenon suggests that long-term elevated gastric pH caused by blockage of the proton-pumps stimulates compensatory gastrin release Interestingly Reimer et al demonstrated the occurrence of RAHS in healthy volunteers who had received eight weeks of esomperazole The clinical symptoms occured in a different prevalence compared with placebo treated patients at ten weeks after withdrawal and until the end of the study twelve weeks Twenty to twenty-two percent of patients displayed symptoms ten or twelve weeks after having discontinued PPIs while they occured in 17-7 of placebo-treated patients Efforts should be pursued to restrict PPI therapy use to patients likely to benefit from it
In this context we propose to investigate the benefit of a progressive decrease in doses of esomeprazole compared to a sudden discontinuation This is a randomized double-blind placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks least randomized to one week of placebo or one week of esomeprazole 20mg We want to compare the prevalence of clinical gastrointestinal symptoms between patients with progressive discontinuation one week of esomeprazole 20mg then discontinuation or those with sudden discontinuation of esomeprazole 40mg
In this context we propose to investigate the benefit of a progressive decrease in doses of esomeprazole compared to a sudden discontinuation This is a randomized double-blind placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks least randomized to one week of placebo or one week of esomeprazole 20mg We want to compare the prevalence of clinical gastrointestinal symptoms between patients with progressive discontinuation one week of esomeprazole 20mg then discontinuation or those with sudden discontinuation of esomeprazole 40mg
Detailed Description:
None
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