Oral Fosamprenavir + Sodium Alginate for GERD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMedical College of Wisconsin
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18-65 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 & Sodium Alginate
Drug1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID
Placebo
Other intervention15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Oral Fosamprenavir-Sodium Alginate (FOS-SA)Experimental treatment 1 intervention
Group B: Oral PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: