NCT06704100

Oral Fosamprenavir + Sodium Alginate for GERD

A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir-Sodium Alginate Administered Orally for 8 Weeks to Patients With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Refractory Gastroesophageal Reflux Disease
• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Fosamprenavir Calcium & Sodium Alginate	1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID
OTHER	Placebo	15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-02-28
• Completion: 2028-06-01
• First posted: 2024-11-25
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study