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NCT06999577 · ClinicalTrials.gov registry record · Phase 4
The Mechanism Versus PPI Trial
A Phase 4 study of Cough and Dysphonia, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT06999577 is a Phase 4 study of Cough and Dysphonia that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 160 participants, below the 209-participant average among 12 other Cough trials with a reported enrollment target (23% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06999577, a Phase 4 study of Cough and Dysphonia, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients. The main question it aims to answer is: Will a greater proportion of the mechanism guided strategy participants achieve symptom response in comparison to the usual care strategy participants? If there is a comparison group: Researchers will compare the mechanism guided strategy to usual care strategy to see if treatment response differs between the groups. Participants will be be asked to do the following: * participate in an 8-week blinded study phase where they will be randomized to either 1) Mechanism Guided Strategy or 2) Usual Care Strategy * take an oral capsule daily (omeprazole 40mg or placebo) * come to 3 in-person visits at UC San Diego Health for an intervention visit with a study provider * consider incorporating recommended lifestyle modifications * complete weekly surveys
Conditions Studied
Interventions
- DRUG Omeprazole 40 MG
- BEHAVIORAL Laryngeal Recalibration Therapy
- BEHAVIORAL GERD Lifestyle Recommendations
Study Locations (1)
California
- University of California San Diego - San Deigo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-06-04 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06999577
The ClinicalTrials.gov registry entry for NCT06999577 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 12 other Cough trials with a reported enrollment target (23% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Cough appearing as the primary indexed condition, and to 3 interventions - of which Omeprazole 40 MG is the first listed.
NCT06999577 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06999577 about?
NCT06999577 is a clinical study titled "The Mechanism Versus PPI Trial". The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care stra...
What is the current status of trial NCT06999577?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2025-06-04. Estimated completion is 2029-07-01.
What conditions does trial NCT06999577 study?
This clinical trial studies the following conditions: Cough, Dysphonia, Laryngopharyngeal Reflux, Reflux, Throat Clearing.
What interventions are being tested in trial NCT06999577?
The interventions under investigation include: Omeprazole 40 MG (DRUG), Laryngeal Recalibration Therapy (BEHAVIORAL), GERD Lifestyle Recommendations (BEHAVIORAL).
Who is sponsoring clinical trial NCT06999577?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06999577 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.