Clinical trial NCT06704100: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
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
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Proof-of-Concept
Primary purpose: TREATMENT

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. 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


Eligibility criteria: Inclusion Criteria:

1. Patient aged 18-65 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).

Primary outcomes:
measure: Weekly Heartburn Severity Score
timeFrame: Ten days of pre-screening and dailyfor 8 weeks.
Secondary outcomes:
measure: Weekly Regurgitation Frequency Score
timeFrame: Ten days of pre-screening and daily for 8 weeks.
measure: Daily modified Reflux Symptom Questionnaire Electronic Diary (mRESQ-eD)
timeFrame: Ten days of pre-screening and daily for 8 weeks.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Nikki Johnston, PhD.
role: PRINCIPAL_INVESTIGATOR
References: