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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID
15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Weekly Heartburn Severity Score
Based on questions 1 and 2 of mRESQ-eD. The percent change from baseline (i.e., Pretreatment) in heartburn severity as indicated by Weekly Heartburn Severity Score (WHSS) at Week 8 (end of Treatment Period). Weekly scoring averaged. \[Minimum Value: 0, Maximum Value: 500, higher score= worse outcome\]
Time frame: Ten days of pre-screening and dailyfor 8 weeks.
Weekly Regurgitation Frequency Score
Based on questions 7 and 7 of mRESQ-eD. The percent change from baseline (i.e., Pretreatment) in regurgitation frequency as indicated by Weekly Regurgitation Frequency Score (WRFS) at Week 8. Weekly scoring averaged. \[Minimum Value: 0, Maximum Value: 400, higher score= worse outcome\]
Time frame: Ten days of pre-screening and daily for 8 weeks.
Daily modified Reflux Symptom Questionnaire Electronic Diary (mRESQ-eD)
The percent change from baseline (i.e., Pretreatment) in symptoms of persistent GERD as indicated by mRESQ-eD weekly total GERD score (WTGS) at Week 8. Weekly scoring averaged. \[Minimum Value: 0, Maximum Value: 1850, higher score= worse outcome\]
Time frame: Ten days of pre-screening and daily for 8 weeks.
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