Oral Fosamprenavir for GERD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-65
SponsorMedical College of Wisconsin
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 50-65 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
Design model
Parallel
Treatments tested in this trial
Fosamprenavir Calcium 700 MG Oral Tablet
Drug1400 mg fosamprenavir BID
Placebo
Other interventionPlacebo pill
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Oral FosamprenavirExperimental treatment 1 intervention
Group B: Oral PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: