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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: Clinical Trial study, sponsored by Columbia University.
NCT01130363 is a clinical trial that was terminated before completion, run by Columbia University. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We 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. We believe there is a correlation between fundic gland polyps of the stomach and use of proton pump inhibiter medications.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2006-10 |
| Est. Completion | 2012-04 |
Why NCT01130363 stopped before completion
NCT01130363 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 23 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01130363 does not publish any study locations in the registry export this page uses.
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.
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