Oral Fosamprenavir + Sodium Alginate for GERD

Phase 2

Not yet recruiting

• Conditions: Refractory Gastroesophageal Reflux Disease; Gastroesophageal Reflux Disease
• Interventions: Drug: Fosamprenavir Calcium & Sodium Alginate; Other: Placebo

• Registration Number: NCT06704100
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Start: 2025-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient aged 18-65 selected as candidate for anti-reflux surgery by study providers.

2. 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.

3. 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:

   1. Erosive esophagitis (Grade A or greater based on the Los Angeles classification of esophagitis; Appendix 3)
   2. 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

4. Patient reports heartburn severity (HS, Item #1 on mRESQ-eD) ≥ 3 (moderate) on at least 2 days and has an average HS of ≥ 2 (mild) during the last 7 days of the Pretreatment Period before Randomization.

Exclusion Criteria

1. Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4.
2. Patient has endoscopically confirmed eosinophilic esophagitis (EE).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Fosamprenavir-Sodium Alginate (FOS-SA)	Fosamprenavir Calcium & Sodium Alginate	Eight weeks of: 1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID, at least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart
Oral Placebo	Placebo	Eight weeks of: 15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate administered BID at least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart

Primary Outcome Measures

Name	Time	Method
Weekly Heartburn Severity Score	Ten days of pre-screening and dailyfor 8 weeks.	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.; \[Minimum Value: 0, Maximum Value: 500, higher score= worse outcome\]

Secondary Outcome Measures

Name	Time	Method
Weekly Regurgitation Frequency Score	Ten days of pre-screening and daily for 8 weeks.	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.; \[Minimum Value: 0, Maximum Value: 400, higher score= worse outcome\]
Daily modified Reflux Symptom Questionnaire Electronic Diary (mRESQ-eD)	Ten days of pre-screening and daily for 8 weeks.	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.; \[Minimum Value: 0, Maximum Value: 1850, higher score= worse outcome\]

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States