The goal of this clinical trial is to learn if study drug Fosamprenavir-Sodium Alginate (FOS-SA) 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 FOS-SA significantly improve heartburn severity over the 8-week treatment period
2. Does FOS-SA significantly improve regurgitation frequency over the 8-week treatment period
3. Does FOS-SA significantly improve symptoms of persistent GERD over the 8-week treatment period
Researchers will compare FOS-SA to a placebo (a look-alike substance that contains no active drug) to see if FOS-SA works to treat PPI-refractory GERD.
Participants will:
1. Take FOS-SA 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
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Patient aged 18-65 selected as candidate for anti-reflux surgery by study providers.
✓. Patient has received, and continued having GERD symptoms during, standard-labeled dose, daily, PPI therapy for a minimum of 8 weeks before the Screening Visit.
✓. Patient has a diagnosis of GERD with endoscopy and/or pH-metry test within the past two years demonstrating 1 or more of the following:
✓. Erosive esophagitis (Grade A or greater based on the Los Angeles classification of esophagitis; Appendix 3)
✓. Evidence of pathological acid reflux (pH \< 4 for ≥ 4-6% off therapy or ≥ 1-4% on therapy) during a 24-hour time interval of pH testing
✓. Patient reports heartburn severity (HS, Item #1 on mRESQ-eD) ≥ 3 (moderate) on at least 2 days and has an average HS of ≥ 2 (mild) during the last 7 days of the Pretreatment Period before Randomization.
Exclusion criteria
✕. Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4.
What they're measuring
1
Weekly Heartburn Severity Score
Timeframe: Ten days of pre-screening and dailyfor 8 weeks.