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The Mechanism Versus PPI Trial

Study acronym: MVP
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Enrolling by Invitation to Recruiting Primary completion date: May 2029 to May 1, 2029 · Completion date: Jul 2029 to Jul 1, 2029 · Site details revisedv4 Show 3 more changesShow less
    • Primary completion date: May 2029 to May 1, 2029
    • Completion date: Jul 2029 to Jul 1, 2029
    • Site details revised
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1 · Start date changed from estimate of Jul 2025 to Jun 4, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2025 to Jun 4, 2025
  3. Secondary endpoints: details revised at 1 of 1 entry Study title shortened, about 11 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06999577
Lead Sponsor University of California, San Diego
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Laryngopharyngeal Reflux, Cough, Throat Clearing, Dysphonia, Reflux
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov