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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
1400 mg fosamprenavir BID
Placebo pill
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Weekly Heartburn Severity Score
The absolute change from baseline (Pretreatment) in heartburn severity as indicated by Weekly Heartburn Severity Score (WHSS; based on items 1 and 2 of the modified Reflux Symptom Questionnaire Electronic Diary, mRESQ-eD) over time, with the primary treatment comparison at Week 8 (End of Treatment)
Time frame: Baseline to Treatment Week 8 (End of Treatment)
Weekly Regurgitation Frequency Score
The absolute change from baseline in regurgitation frequency as indicated by Weekly Regurgitation Frequency Score (WRFS; based on items 6 and 7 of the mRESQ-eD) over time, with the primary treatment comparison at Week 8.
Time frame: Baseline to Treatment Week 8 (End of Treatment)
Weekly Heartburn-free Days
The absolute change from baseline in weekly heartburn-free days as indicated by Weekly Heartburn-Free Days (WHFD; i.e. the total number of symptom-free days per week, with symptom-free defined as "Did not have" response to items 1 and 2 of the mRESQ-eD), over time, with the primary treatment comparison at Week 8.
Time frame: Baseline to Treatment Week 8 (End of Treatment)
Weekly Overall Reflux Symptom-free Days
The absolute change from baseline in weekly overall reflux symptom-free days as indicated by Weekly Symptom-Free Days (WSFD; i.e. the total number of symptom-free days per week, with symptom-free defined as "Did not have" or "Never" response to all items of the mRESQ-eD), over time, with the primary treatment comparison at Week 8.
Time frame: Baseline to Treatment Week 8 (End of Treatment)
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