Oral Fosamprenavir + Sodium Alginate for GERD

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06704100
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastroesophageal Reflux Disease
  • Refractory Gastroesophageal Reflux Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

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
  • Placebo — OTHER
    15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate

Study Details

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

Key Dates

Start date
Mar 1, 2026
Status verified
Oct 2025
Primary completion
Feb 28, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Fosamprenavir-Sodium Alginate (FOS-SA)
    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
  • Placebo Comparator: Oral Placebo
    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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226
Ally Lesnick, BSc.
[email protected]
414-955-2659

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