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Oral Fosamprenavir + Sodium Alginate for GERD

NCT06704100 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Nikki Johnston, PhD. · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-02-28
Completion
2028-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704100 on ClinicalTrials.gov