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NCT04383262 · ClinicalTrials.gov registry record · Phase 2
Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT04383262 is a Phase 2 study that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 104 participants.
The verdict
NCT04383262, a Phase 2 study, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
Laryngopharyngeal Reflux (LPR) is a common condition that causes symptoms like chronic cough, throat clearing, hoarseness, and trouble swallowing. If not treated, LPR can lead to long-term throat damage and may increase the risk of throat cancer. More than 20% of the people in the United States are estimated to have LPR, yet there is no effective medication approved to treat it. Drugs called proton pump inhibitors (PPIs) are often used to treat LPR, even though they were designed for stomach acid problems. These medications reduce acid but do not stop reflux from happening, so they often do not help LPR patients. Despite poor results, PPIs are widely prescribed, are very costly, and can cause side effects. Research shows that a digestive enzyme called pepsin plays a key role in LPR. Pepsin can damage the throat and voice box even when acid is not present. Laboratory studies found that certain HIV medications can block damage caused by pepsin. People taking these medications for HIV appear to have a much lower rate of LPR. This study will test fosamprenavir, an FDA-approved HIV drug, as a treatment for LPR. We will conduct a 14-week, double-blind, placebo-controlled clinical trial in patients with LPR who did not improve with standard treatment. Participants will receive either fosamprenavir or placebo, randomly, and symptoms will be measured before and after treatment using standard questionnaires and daily symptom tracking. Because there is no effective medical treatment for LPR. this study aims to test a safe, existing drug that targets the underlying cause of the disease.
Interventions
- OTHER Placebo
- DRUG Fosamprenavir Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04383262
The ClinicalTrials.gov registry entry for NCT04383262 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04383262 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04383262 about?
NCT04383262 is a clinical study titled "Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction". Laryngopharyngeal Reflux (LPR) is a common condition that causes symptoms like chronic cough, throat clearing, hoarseness, and trouble swallowing. If not treated, LPR can lead to long-term throat damage and may increase the risk of throat cancer. More than 20% of the people in the United States are ...
What is the current status of trial NCT04383262?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2026-07-15. Estimated completion is 2028-10-01.
What interventions are being tested in trial NCT04383262?
The interventions under investigation include: Placebo (OTHER), Fosamprenavir Calcium (DRUG).
Who is sponsoring clinical trial NCT04383262?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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