BridgeMD
Compares treatment options for Laryngopharyngeal Reflux
Official title The Mechanism Versus PPI Trial
ClinicalTrials.gov ID: NCT06999577
What this study is testing
What is Omeprazole 40 MG?
Omeprazole 40 MG is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for laryngopharyngeal reflux.
Also referred to as Prilosec, NDA 21-229.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Deigo, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Deigo, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.