Fosamprenavir + Sodium Alginate for GERD
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.12345
Is Fosamprenavir + Sodium Alginate safe for humans?
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.311121314
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 period2. Does FOS-SA significantly improve regurgitation frequency over the 8-week treatment period3. Does FOS-SA significantly improve symptoms of persistent GERD over the 8-week treatment periodResearchers 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 weeks2. Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests3. 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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FOS-SA or placebo orally twice a day for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fosamprenavir
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor