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Oral Fosamprenavir for GERD

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jan 1, 2027 to Oct 1, 2027 Interventions modified · Eligibility criteria revised · Secondary endpoints: 2 to 3 · 1 morev5 Show 4 more changesShow less
    • Interventions modified
    • Eligibility criteria revised
    • Secondary endpoints: 2 to 3
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Feb 28, 2028 to Dec 31, 2028 Start date: Mar 1, 2026 to Jan 1, 2027 · Completion date: Jun 1, 2028 to Mar 1, 2029v4 Show 2 more changesShow less
    • Start date: Mar 1, 2026 to Jan 1, 2027
    • Completion date: Jun 1, 2028 to Mar 1, 2029
  3. Primary completion date: May 1, 2027 to Feb 28, 2028 Start date: May 1, 2025 to Mar 1, 2026 · Completion date: Sep 1, 2027 to Jun 1, 2028v3 Show 2 more changesShow less
    • Start date: May 1, 2025 to Mar 1, 2026
    • Completion date: Sep 1, 2027 to Jun 1, 2028
  4. Secondary endpoints: details revised at 2 of 2 entriesv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study drug Fosamprenavir administered orally improves symptoms for Proton Pump Inhibitor (PPI)-refractory Gastro Esophageal Reflux Disease (GERD). The main questions it aims to answer are: 1. Does fosamprenavir significantly improve heartburn severity over the 8-week treatment period 2. Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period 3. Does fosamprenavir significantly improve symptoms of persistent GERD over the 8-week treatment period Researchers will compare fosamprenavir to a placebo (a look-alike substance that contains no active drug) to see if fosamprenavir works to treat PPI-refractory GERD. Participants will: 1. Take fosamprenavir or placebo every day BID (twice a day) for 8 weeks 2. Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests 3. Keep a daily diary of their symptoms of persistent GERD
Trial Details
NCT Number NCT06704100
Lead Sponsor Medical College of Wisconsin
Conditions Refractory Gastroesophageal Reflux Disease, Gastroesophageal Reflux Disease
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov