Oral Fosamprenavir for GERD

A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir Administered Orally for 8 Weeks in Older Adults With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease

The goal of this clinical trial is to learn if study drug Fosamprenavir 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 fosamprenavir significantly improve heartburn severity over the 8-week treatment period
2. Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period
3. Does fosamprenavir significantly improve symptoms of persistent GERD over the 8-week treatment period

Researchers will compare fosamprenavir to a placebo (a look-alike substance that contains no active drug) to see if fosamprenavir works to treat PPI-refractory GERD.

Participants will:

1. Take fosamprenavir 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

Study Overview

• Status: Not yet recruiting
• Conditions: Gastroesophageal Reflux Disease; Refractory Gastroesophageal Reflux Disease
• Intervention / Treatment: Other: Placebo; Drug: Fosamprenavir Calcium 700 MG Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ally Lesnick, BSc; Phone Number: 414-955-2659; Email: alesnick@mcw.edu
• Study Contact Backup: Name: Nikki Johnston, PhD.; Phone Number: 414-955-4075; Email: njohnston@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
      • Contact: Ally Lesnick, BSc.; Phone Number: 414-955-2659; Email: alesnick@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient aged 50-65 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Fosamprenavir; Eight weeks of: 1400 mg fosamprenavir BID: At least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart	Drug: Fosamprenavir Calcium 700 MG Oral Tablet; 1400 mg fosamprenavir BID
Placebo Comparator: Oral Placebo; Eight weeks of: Placebo Pill	Other: Placebo; Placebo pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly Heartburn Severity Score	The absolute change from baseline (Pretreatment) in heartburn severity as indicated by Weekly Heartburn Severity Score (WHSS; based on items 1 and 2 of the modified Reflux Symptom Questionnaire Electronic Diary, mRESQ-eD) over time, with the primary treatment comparison at Week 8 (End of Treatment)	Baseline to Treatment Week 8 (End of Treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly Regurgitation Frequency Score	The absolute change from baseline in regurgitation frequency as indicated by Weekly Regurgitation Frequency Score (WRFS; based on items 6 and 7 of the mRESQ-eD) over time, with the primary treatment comparison at Week 8.	Baseline to Treatment Week 8 (End of Treatment)
Weekly Heartburn-free Days	The absolute change from baseline in weekly heartburn-free days as indicated by Weekly Heartburn-Free Days (WHFD; i.e. the total number of symptom-free days per week, with symptom-free defined as "Did not have" response to items 1 and 2 of the mRESQ-eD), over time, with the primary treatment comparison at Week 8.	Baseline to Treatment Week 8 (End of Treatment)
Weekly Overall Reflux Symptom-free Days	The absolute change from baseline in weekly overall reflux symptom-free days as indicated by Weekly Symptom-Free Days (WSFD; i.e. the total number of symptom-free days per week, with symptom-free defined as "Did not have" or "Never" response to all items of the mRESQ-eD), over time, with the primary treatment comparison at Week 8.	Baseline to Treatment Week 8 (End of Treatment)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Nikki Johnston, PhD., Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Fosamprenavir; PPI-refractory GERD; Proton pump inhibitor refractory gastroesophageal reflux disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Pharmaceutical Preparations; Dosage Forms; Tablets; fosamprenavir
• Other Study ID Numbers: PRO000000000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No