Fosamprenavir + Sodium Alginate for GERD

Overseen By Ally Lesnick, BSc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must be taking: Proton pump inhibitors

Disqualifiers: Functional dyspepsia, Functional heartburn, Eosinophilic esophagitis

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FOS-SA (a combination of Fosamprenavir and Sodium Alginate) to determine its effectiveness for people with GERD, a condition causing heartburn and acid reflux, who haven't found relief with standard medications known as PPIs. Researchers aim to discover if FOS-SA can reduce heartburn severity, decrease regurgitation, and improve overall GERD symptoms over 8 weeks. Participants will either take FOS-SA or a placebo and visit the research unit for checkups. This trial may suit those who have tried PPIs for at least 8 weeks without success and have been recommended for anti-reflux surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves patients who continue to have GERD symptoms despite taking PPIs, you might be expected to continue your current PPI therapy during the trial.

Is there any evidence suggesting that Fosamprenavir-Sodium Alginate is likely to be safe for humans?

Research has shown that sodium alginate can help with GERD (gastroesophageal reflux disease) by reducing symptoms like heartburn and regurgitation. While specific safety information for the combination of fosamprenavir and sodium alginate (FOS-SA) is not available, existing knowledge about each component can be considered.

Fosamprenavir, used for other health issues, is generally well-tolerated and might cause mild side effects like nausea or headache, which are usually manageable. Sodium alginate is commonly used for GERD symptoms and is considered safe with few side effects.

As this trial is in an early stage, the safety of the treatment is still under careful study. However, no major safety concerns have been identified so far based on available information. Participants in the trial will be monitored to ensure the treatment remains safe and comfortable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for GERD?

Unlike the standard GERD treatments, which typically include proton pump inhibitors or H2 blockers, the combination of Fosamprenavir and sodium alginate offers a unique approach. Fosamprenavir is an antiretroviral drug that's being repurposed here, potentially providing a novel mechanism by possibly modifying acid secretion pathways differently than traditional options. Additionally, sodium alginate forms a physical barrier that helps prevent acid reflux, offering a dual-action strategy that could enhance symptom relief. Researchers are excited because this combination might improve efficacy and patient outcomes by addressing GERD through both chemical and mechanical means.

What evidence suggests that Fosamprenavir-Sodium Alginate might be an effective treatment for GERD?

Research has shown that sodium alginate, a key component of the Fosamprenavir-Sodium Alginate (FOS-SA) treatment, effectively reduces symptoms of gastroesophageal reflux disease (GERD). It creates a barrier that prevents stomach acid from irritating the esophagus. In this trial, participants will receive either the FOS-SA combination or a placebo. Although Fosamprenavir is typically used for other health issues, early research suggests it might also alleviate GERD symptoms, particularly when common treatments like proton pump inhibitors (PPIs) are ineffective. This combination aims to improve heartburn and reduce regurgitation, offering hope to those with persistent GERD symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Nikki Johnston, PhD.

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for individuals with GERD who haven't found relief from Proton Pump Inhibitors. Participants will be required to take the study drug or placebo twice daily, visit the research unit seven times, and keep a diary of their symptoms.

Inclusion Criteria

I have GERD confirmed by tests and experience moderate to severe heartburn.

I've been on daily acid reflux medication for over 8 weeks but still have symptoms.

Exclusion Criteria

I am suspected to have a stomach or heartburn issue not caused by an obvious disease.

My esophagus inflammation was confirmed by a scope test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive FOS-SA or placebo orally twice a day for 8 weeks

8 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fosamprenavir

Trial Overview The trial tests if Fosamprenavir-Sodium Alginate (FOS-SA) can improve heartburn severity, regurgitation frequency, and other persistent GERD symptoms over an 8-week period compared to a placebo.

How Is the Trial Designed?

Group I: Oral Fosamprenavir-Sodium Alginate (FOS-SA) Experimental Treatment 1 Intervention

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

Group II: Oral Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Eluxadoline is associated with a significant risk of pancreatitis, accounting for 16.4% of adverse event reports, with 53 cases requiring hospitalization, highlighting a serious safety concern.

Compared to other antidiarrheal medications, the incidence of pancreatitis linked to eluxadoline is markedly higher, suggesting a need for reevaluation of its risk-benefit profile, especially in light of recent fatalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline. Gawron, AJ., Bielefeldt, K.[2019]

Adverse drug reactions (ADRs) are a significant issue in pharmacotherapy, costing the U.S. healthcare system up to $30.1 billion annually, with about 10% of ADRs affecting the gastrointestinal tract.

Common ADRs include xerostomia in the oral cavity, esophageal irritation from NSAIDs, and drug-induced diarrhea from antibiotics and laxatives, highlighting the importance of physician awareness to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tract as a side-effect target of medications. Domagała-Rodacka, R., Cibor, D., Szczeklik, K., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06704100

Oral Fosamprenavir + Sodium Alginate for GERD Study Overview · Does FOS-SA significantly improve heartburn severity over the 8-week treatment period · Does FOS-SA significantly improve regurgitation frequency ...

2. clinconnect.io clinconnect.io/trials/NCT06704100

Oral Fosamprenavir + Sodium Alginate for GERD - ClinConnect The goal of this clinical trial is to learn if study drug Fosamprenavir-Sodium Alginate (FOS-SA) administered orally improves symptoms for Proton Pump ...

3. withpower.com withpower.com/trial/phase-2-refractory-gastroesophageal-reflux-disease-4-2025-81489

Fosamprenavir + Sodium Alginate for GERD Research shows that sodium alginate, a component of the treatment, is effective in reducing symptoms of gastroesophageal reflux disease (GERD) by forming a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732152/

Oral and inhaled fosamprenavir reverses pepsin-induced ... While PPI therapy is a mainstay in the treatment of GER disease (GERD), its efficacy for LPR is poor20–23.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06704100?intr=FOSAMPRENAVIR%20SODIUM&aggFilters=studyType:int&viewType=Table&rank=2

Oral Fosamprenavir + Sodium Alginate for GERD 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10095080/

The Protease Inhibitor Amprenavir Protects against Pepsin- ... These results support a potential therapeutic role for amprenavir in GERD recalcitrant to PPI therapy and for preventing GERD-associated ...

7. clinicaltrials.eu clinicaltrials.eu/inn/sodium-alginate/

Sodium Alginate: A Comprehensive Guide for Patients For GERD and NERD: Sodium alginate has been shown to be effective in reducing symptoms like heartburn and regurgitation.