Oral Fosamprenavir + Sodium Alginate for GERD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMedical College of Wisconsin
About this trial
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
Eligibility criteria
Qualifiers
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.
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
Disqualifiers
Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4.
Patient has endoscopically confirmed eosinophilic esophagitis (EE).
Trial design
Treatments tested in this trial
- Fosamprenavir Calcium & Sodium Alginate
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov