A Phase 2 interventional study of Fosamprenavir Calcium 700 MG Oral Tablet and Placebo in Refractory Gastroesophageal Reflux Disease and Gastroesophageal Reflux Disease, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Medical College of Wisconsin · Phase 2, Interventional, and Treatment
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:
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:
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:
Exclusion Criteria:
Eight weeks of: 1400 mg fosamprenavir BID: At least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart
Drug: Fosamprenavir Calcium 700 MG Oral Tablet
Eight weeks of: Placebo Pill
Other: Placebo
1400 mg fosamprenavir BID
Placebo pill
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)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin