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NCT06704100 · ClinicalTrials.gov registry record · Phase 2
Oral Fosamprenavir + Sodium Alginate for GERD
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT06704100: Clinical Trial Phase 2 study, sponsored by Medical College of Wisconsin.
NCT06704100 is a Phase 2 study that has not yet begun recruiting, run by Medical College of Wisconsin. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06704100, a Phase 2 study, has not yet begun recruiting, sponsored by Medical College of Wisconsin.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
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
Primary Outcome
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. \[Minimum Value: 0, Maximum Value: 500, higher score= worse outcome\]
Interventions
- OTHER Placebo
- DRUG Fosamprenavir Calcium & Sodium Alginate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 2 |
What is known before NCT06704100 opens enrollment
NCT06704100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06704100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06704100 about?
NCT06704100 is a clinical study titled "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 (PPI)-refractory Gastro Esophageal Reflux Disease (GERD). The main questions it aims to answer are: 1. Does FOS-SA significantly improve ...
What is the current status of trial NCT06704100?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2027-01-01. Estimated completion is 2029-03-01.
What interventions are being tested in trial NCT06704100?
The interventions under investigation include: Placebo (OTHER), Fosamprenavir Calcium & Sodium Alginate (DRUG).
Who is sponsoring clinical trial NCT06704100?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06704100's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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