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Oral Fosamprenavir for GERD
Sponsor: Medical College of Wisconsin
Summary
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
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir Administered Orally for 8 Weeks in Older Adults With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease
Key Details
Gender
All
Age Range
50 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2027-10-01
Completion Date
2029-03-01
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
Fosamprenavir Calcium 700 MG Oral Tablet
1400 mg fosamprenavir BID
Placebo
Placebo pill
Locations (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, United States