Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01130363
Status:
TERMINATED
Last Update Posted:
2012-07-02
First Post:
2010-05-21
Brief Title:
Fundic Gland Polyps and Proton Pump Inhibitor PPI Drugs
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The class of proton pump inhibitor PPI medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers Although the FDA approval for PPI therapy is limited to 6-8 weeks many individuals remain on these agents for years and human studies have suggested that long-term use of a PPI can result in enterochromaffin-like ECL cell hyperplasia as well as being associated with the development of fundic-gland polyps of the stomach These findings raise the concern of the possibility that long-term use of PPIs may predispose to the development of neuroendocrine tumors in patients The investigators aim to examine clinical parameters including history of PPI use and fasting gastrin levels as well as histologic characteristics particularly the presence of ECL-cell hyperplasia of patients found to have fundic gland polyps during endoscopy The investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications
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