Status:
RECRUITING
The Mechanism Versus PPI Trial
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Laryngopharyngeal Reflux
Cough
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief 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 undergoi...
Detailed Description
This research study is being conducted to compare the efficacy between usual care and a novel mechanism guided strategy for adults with chronic throat (laryngeal) symptoms undergoing evaluation for la...
Eligibility Criteria
Inclusion
- 18-89 years of age
- \>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia)
- Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression
- Off acid suppression therapy for at least 2 weeks prior to randomization.
Exclusion
- PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles
- History of foregut surgery
- Known diagnosis of achalasia
- Inability to fast for 4 hours (no food or drink)
- Active tobacco use
- Pregnant or breastfeeding
- Unable to consent in English or Spanish
- Unable to provide consent without a legal guardian or representative
- Imprisoned
- Endoscopic findings conclusive with esophageal mucosal abnormalities
- Unable to proceed with reflux monitoring
- Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed
- Prior LRT for reflux related symptoms
- History of major psychiatric comorbidity
- Unable to attend in person study visits at UCSD
Key Trial Info
Start Date :
June 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06999577
Start Date
June 4 2025
End Date
July 1 2029
Last Update
August 1 2025
Active Locations (1)
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1
University of California San Diego
San Deigo, California, United States, 92093