Fosamprenavir + Sodium Alginate for GERD

Phase 2

Waitlist Available

Led By Nikki Johnston, PhD.

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Patient is suspected of having functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria

Patient has endoscopically confirmed eosinophilic esophagitis (EE)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ten days of pre-screening and dailyfor 8 weeks.

Summary

This trial aims to see if a new drug called Fosamprenavir-Sodium Alginate (FOS-SA) taken by mouth can help improve symptoms for people with Gastro Esophageal

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed in the provided information. Typically, participants will be monitored for any adverse reactions throughout the trial.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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My esophagus inflammation was confirmed by a scope test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ten days of pre-screening and dailyfor 8 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ten days of pre-screening and dailyfor 8 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and ten days of pre-screening and dailyfor 8 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weekly Heartburn Severity Score

Secondary study objectives

Daily modified Reflux Symptom Questionnaire Electronic Diary (mRESQ-eD)

Weekly Regurgitation Frequency Score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral Fosamprenavir-Sodium Alginate (FOS-SA)Experimental Treatment1 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 PlaceboPlacebo Group1 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

0 / 2Eligibility criteria met