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NCT01095133 · ClinicalTrials.gov registry record · Phase 1
Do Acid Sensing Ion Channels Contribute to Heartburn?
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01095133: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01095133 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01095133, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this research study is to learn about whether treating the esophagus with amiloride reduces either the frequency or the time to onset of acid-induced heartburn in patients with nonerosive reflux disease. In particular, we are looking at people who have either had complete relief while using a Proton Pump Inhibitor (PPI) or who have only had some relief of symptoms while on a PPI.
Primary Outcome
Subjects have esophageal perfusion with active agent or placebo followed by esophageal perfusion with HCl until heartburn occurs or 15 min is reached without heartburn. Time to onset of heartburn is compared for each arm of the study. There is no months or years issue here. It is an acute study with a time frame of minutes to heartburn during acid perfusion. The study begins and ends with the acid perfusion test, there is durable treatment other than two five minute perfusions of the esophagus w
Interventions
- DRUG Placebo
- DRUG Amiloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01095133 record still lists
NCT01095133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01095133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01095133 about?
NCT01095133 is a clinical study titled "Do Acid Sensing Ion Channels Contribute to Heartburn?". The purpose of this research study is to learn about whether treating the esophagus with amiloride reduces either the frequency or the time to onset of acid-induced heartburn in patients with nonerosive reflux disease. In particular, we are looking at people who have either had complete relief while...
What is the current status of trial NCT01095133?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-03. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01095133?
The interventions under investigation include: Placebo (DRUG), Amiloride (DRUG).
Who is sponsoring clinical trial NCT01095133?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01095133's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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