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NCT01317472 · ClinicalTrials.gov registry record · NA
The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01317472: Clinical Trial NA study, sponsored by Indiana University.
NCT01317472 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01317472, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide laryngopharyngeal reflux (LPR) symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. It is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.
Primary Outcome
The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of \>13 is considered to be abnormal.
Interventions
- DRUG Placebo
- DRUG dexlansoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-11 |
| Phase | NA |
Why NCT01317472 stopped before completion
NCT01317472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01317472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01317472 about?
NCT01317472 is a clinical study titled "The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux". Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring...
What is the current status of trial NCT01317472?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2011-03. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01317472?
The interventions under investigation include: Placebo (DRUG), dexlansoprazole (DRUG).
Who is sponsoring clinical trial NCT01317472?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01317472's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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