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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment 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 barrier that prevents acid from rising into the esophagus. Studies have demonstrated that alginate-based therapies significantly improve GERD symptoms compared to placebo or antacids. ^{1 2 3 4 5}

Is Fosamprenavir + Sodium Alginate safe for humans?

The provided research articles do not contain specific safety data for Fosamprenavir + Sodium Alginate. However, general information on adverse drug reactions (unwanted effects from medications) highlights the importance of monitoring and reporting any side effects to ensure patient safety. ^{6 7 8 9 10}

How does the drug Fosamprenavir + Sodium Alginate differ from other GERD treatments?

Fosamprenavir combined with sodium alginate for GERD is unique because it pairs an antiretroviral drug with an alginate, which works by forming a barrier to prevent acid reflux, unlike traditional acid-suppressing medications like proton pump inhibitors (PPIs). This combination may offer an alternative for patients who do not respond well to standard GERD treatments. ^{3 11 12 13 14}

What is the purpose of this trial?

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

Research Team

Nikki Johnston, PhD.

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Alginate controls heartburn in patients with erosive and nonerosive reflux disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of a Natural Remedy for the Treatment of Gastroesophageal Reflux: A Double-Blinded Randomized-Controlled Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Alginate therapy is effective treatment for GERD symptoms: a systematic review and meta-analysis. [2018]

4. India pubmed.ncbi.nlm.nih.gov

The suppression of gastro-oesophageal reflux by alginates. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Phytotherapeutische Ansätze zur Behandlung des laryngopharyngealen Reflux in der HNO-Praxis]. [2021]

6. France pubmed.ncbi.nlm.nih.gov

General medicine and notification of adverse reactions: contributions of health insurance representatives [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Good pharmacovigilance practices: technology enabled. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline. [2019]

9. France pubmed.ncbi.nlm.nih.gov

[Clinical assessment of drug safety]. [2019]

10. Poland pubmed.ncbi.nlm.nih.gov

Gastrointestinal tract as a side-effect target of medications. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Alginate therapy is effective treatment for gastroesophageal reflux disease symptoms: a systematic review and meta-analysis. [2022]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Using gaviscon preparation for relief of esophageal, extraesophageal syndromes and functional dyspepsia in elderly patients with GERD]. [2013]

13. Egypt pubmed.ncbi.nlm.nih.gov

Evaluation of an Innovative Over-the-Counter Treatment for Symptoms of Reflux Disease: Quick-Dissolving Alginate Granules. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial. [2018]