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NCT Number: NCT06704100

Oral Fosamprenavir + Sodium Alginate for GERD

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

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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:
  • 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
  • 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

  • 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).

Treatment and study plan

Fosamprenavir Calcium & Sodium Alginate

Drug

1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID

Placebo

Other

15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate

Other names: Microcrystalline cellulose, Sodium Alginate

Primary outcomes

  1. Weekly Heartburn Severity Score

    Time frame: 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 outcomes

  1. Weekly Regurgitation Frequency Score

    Time frame: 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]

  2. Daily modified Reflux Symptom Questionnaire Electronic Diary (mRESQ-eD)

    Time frame: 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]

Study contacts

Contact information is provided by the study sponsor or research team.

Ally Lesnick, BSc

CONTACT

[email protected]

414-955-2659

Nikki Johnston, PhD.

CONTACT

[email protected]

414-955-4075

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Nov 25, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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