Oral Fosamprenavir + Sodium Alginate for GERD
This study is testing if an oral solution called Fosamprenavir Calcium & Sodium Alginate (FOS-SA) can help improve symptoms of Gastroesophageal Reflux Disease (GERD) that hasn't gotten better with standard Proton Pump Inhibitor (PPI) medications. Researchers want to see if FOS-SA can reduce heartburn severity, how often you experience regurgitation, and other ongoing GERD symptoms over an 8-week period. They will compare FOS-SA to a placebo, which looks the same but contains no active drug. You might be able to join if you are between 18 and 64 years old, have ongoing GERD symptoms despite taking PPIs for at least 8 weeks, and have a GERD diagnosis confirmed by endoscopy or pH-metry within the last two years. The study aims to enroll 60 participants.
- Study design
- This is an interventional study comparing Fosamprenavir Calcium & Sodium Alginate to a placebo, with a planned enrollment of 60 participants.
- What's involved
- Participants will take either Fosamprenavir Calcium & Sodium Alginate or a placebo orally twice a day for 8 weeks. Heartburn severity will be measured daily for 8 weeks after a 10-day pre-screening period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Heartburn severity will be measured daily for 8 weeks after a 10-day pre-screening period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Oral Fosamprenavir + Sodium Alginate for GERD
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nikki Johnston, PhD. · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Who to contact
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What this trial measures
- Weekly Heartburn Severity ScoreTen days of pre-screening and dailyfor 8 weeks.
Based on questions 1 and 2 of mRESQ-eD. The percent change from baseline (i.e., Pretreatment) in heartburn severity as indicated by Weekly Heartburn Severity Score (WHSS) at Week 8 (end of Treatment Period). Weekly scoring averaged. \[Minimum Value: 0, Maximum Value: 500, higher score= worse outcome\]