Oral Fosamprenavir 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 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 fosamprenavir significantly improve heartburn severity over the 8-week treatment period
2. 2.Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period
3. 3.Does fosamprenavir significantly improve symptoms of persistent GERD over the 8-week treatment period
4. 4.Take fosamprenavir 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Weekly Regurgitation Frequency Score

  Baseline to Treatment Week 8 (End of Treatment)

• Weekly Heartburn-free Days

  Baseline to Treatment Week 8 (End of Treatment)

• Weekly Overall Reflux Symptom-free Days

  Baseline to Treatment Week 8 (End of Treatment)

Study Arms (2)

Oral Fosamprenavir

EXPERIMENTAL

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

Oral Placebo

PLACEBO COMPARATOR

Eight weeks of: Placebo Pill

Other: Placebo

Interventions

Placebo OTHER

Placebo pill

Oral Placebo

Fosamprenavir Calcium 700 MG Oral Tablet DRUG

1400 mg fosamprenavir BID

Oral Fosamprenavir

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 50-65 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; Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

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): October 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

US (1)