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NCT01130363 · ClinicalTrials.gov registry record

Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs

A clinical trial, sponsored by Columbia University.

Terminated
Registry status
23
Enrollment target

NCT01130363 is a clinical trial that was terminated before completion, run by Columbia University. The registered enrollment target is 23 participants.

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The verdict

NCT01130363 was terminated before completion, sponsored by Columbia University.

TERMINATED
Registry status
23 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2006-10
Est. Completion 2012-04

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT01130363

The ClinicalTrials.gov registry entry for NCT01130363 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01130363 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01130363 about?

NCT01130363 is a clinical study titled "Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs". 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 studi...

What is the current status of trial NCT01130363?

This trial is currently terminated. The enrollment target is 23 participants. The study started on 2006-10. Estimated completion is 2012-04.

Who is sponsoring clinical trial NCT01130363?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.