Oral Fosamprenavir + Sodium Alginate for GERD

Official 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

Overview

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

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

Primary outcome measures

• Weekly Heartburn Severity Score [Time frame: Ten days of pre-screening and dailyfor 8 weeks.]

Secondary outcome measures (2)

• Weekly Regurgitation Frequency Score [Time frame: Ten days of pre-screening and daily for 8 weeks.]
• Daily modified Reflux Symptom Questionnaire Electronic Diary (mRESQ-eD) [Time frame: Ten days of pre-screening and daily for 8 weeks.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Medical College of Wisconsin — Milwaukee

Identifiers

NCT: NCT06704100 · PRO000000000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗