Oral Fosamprenavir + Sodium Alginate for GERD

NCT06704100 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO000000000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Does FOS-SA significantly improve heartburn severity over the 8-week treatment period
2. 2.Does FOS-SA significantly improve regurgitation frequency over the 8-week treatment period
3. 3.Does FOS-SA significantly improve symptoms of persistent GERD over the 8-week treatment period
4. 4.Take FOS-SA or placebo every day BID (twice a day) for 8 weeks
5. 5.Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests
6. 6.Keep a daily diary of their symptoms of persistent GERD

Conditions

Refractory Gastroesophageal Reflux Disease; Gastroesophageal Reflux Disease

Keywords

PPI-refractory GERD; Proton pump inhibitor refractory gastroesophageal reflux disease; Fosamprenavir; Sodium Alginate; Fosamprenavir-Sodium Alginate; FOS-SA

Outcome Measures

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. \[Minimum Value: 0, Maximum Value: 500, higher score= worse outcome\]

  Ten days of pre-screening and dailyfor 8 weeks.

Secondary Outcomes (2)

• Weekly Regurgitation Frequency Score

  Ten days of pre-screening and daily for 8 weeks.

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

  Ten days of pre-screening and daily for 8 weeks.

Study Arms (2)

Oral Fosamprenavir-Sodium Alginate (FOS-SA)

EXPERIMENTAL

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

Drug: Fosamprenavir Calcium & Sodium Alginate

Oral Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Oral Fosamprenavir-Sodium Alginate (FOS-SA)

Placebo OTHER

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

Also known as: Microcrystalline cellulose, Sodium Alginate

Oral Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

fosamprenavir; Alginates; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Study Officials

• Nikki Johnston, PhD.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ally Lesnick, BSc

CONTACT

414-955-2659; alesnick@mcw.edu

Nikki Johnston, PhD.

CONTACT

414-955-4075; njohnston@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We have partnered with Froedtert Hospital's Investigative Drug Services (FH IDS) in order to randomize subjects to either treatment or placebo. Only FH IDS will have the key linking subjects to treatment groups, and the power to conduct an emergency un-blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Proof-of-Concept

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

US (1)