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Not yet recruitingNCT06704100Updated Sep 10, 2026

Oral Fosamprenavir for GERD

A Phase 2 interventional study of Fosamprenavir Calcium 700 MG Oral Tablet and Placebo in Refractory Gastroesophageal Reflux Disease and Gastroesophageal Reflux Disease, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Medical College of Wisconsin · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if study drug Fosamprenavir 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 fosamprenavir significantly improve heartburn severity over the 8-week treatment period
  2. Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period
  3. Does fosamprenavir significantly improve symptoms of persistent GERD over the 8-week treatment period

Researchers will compare fosamprenavir to a placebo (a look-alike substance that contains no active drug) to see if fosamprenavir works to treat PPI-refractory GERD.

Participants will:

  1. Take fosamprenavir 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
02

Conditions studied

  • Refractory Gastroesophageal Reflux Disease
  • Gastroesophageal Reflux Disease

Keywords

  • PPI-refractory GERD
  • Proton pump inhibitor refractory gastroesophageal reflux disease
  • Fosamprenavir
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's planned enrollment of 60 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.

Browse Medical College of Wisconsin studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient aged 50-65 selected as candidate for anti-reflux surgery by study providers.
  2. Patient has received, and continued having GERD symptoms during, standard-labeled dose, daily, PPI therapy for a minimum of 8 weeks before the Screening Visit.

  3. Patient has a diagnosis of GERD with endoscopy and/or pH-metry test within the past two years demonstrating 1 or more of the following:

    1. Erosive esophagitis (Grade A or greater based on the Los Angeles classification of esophagitis; Appendix 3)
    2. Evidence of pathological acid reflux (pH \< 4 for ≥ 4-6% off therapy or ≥ 1-4% on therapy) during a 24-hour time interval of pH testing
  4. Patient reports heartburn severity (HS, Item #1 on mRESQ-eD) ≥ 3 (moderate) on at least 2 days and has an average HS of ≥ 2 (mild) during the last 7 days of the Pretreatment Period before Randomization.

Exclusion criteria

Exclusion Criteria:

  1. Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4.
  2. Patient has endoscopically confirmed eosinophilic esophagitis (EE).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Oral Fosamprenavir

    Eight weeks of: 1400 mg fosamprenavir BID: At least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart

    Drug: Fosamprenavir Calcium 700 MG Oral Tablet

  • Placebo comparator
    Oral Placebo

    Eight weeks of: Placebo Pill

    Other: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Weekly Heartburn Severity Score

    The absolute change from baseline (Pretreatment) in heartburn severity as indicated by Weekly Heartburn Severity Score (WHSS; based on items 1 and 2 of the modified Reflux Symptom Questionnaire Electronic Diary, mRESQ-eD) over time, with the primary treatment comparison at Week 8 (End of Treatment)

    Time frame: Baseline to Treatment Week 8 (End of Treatment)

Secondary outcomes

  1. Weekly Regurgitation Frequency Score

    The absolute change from baseline in regurgitation frequency as indicated by Weekly Regurgitation Frequency Score (WRFS; based on items 6 and 7 of the mRESQ-eD) over time, with the primary treatment comparison at Week 8.

    Time frame: Baseline to Treatment Week 8 (End of Treatment)

  2. Weekly Heartburn-free Days

    The absolute change from baseline in weekly heartburn-free days as indicated by Weekly Heartburn-Free Days (WHFD; i.e. the total number of symptom-free days per week, with symptom-free defined as "Did not have" response to items 1 and 2 of the mRESQ-eD), over time, with the primary treatment comparison at Week 8.

    Time frame: Baseline to Treatment Week 8 (End of Treatment)

  3. Weekly Overall Reflux Symptom-free Days

    The absolute change from baseline in weekly overall reflux symptom-free days as indicated by Weekly Symptom-Free Days (WSFD; i.e. the total number of symptom-free days per week, with symptom-free defined as "Did not have" or "Never" response to all items of the mRESQ-eD), over time, with the primary treatment comparison at Week 8.

    Time frame: Baseline to Treatment Week 8 (End of Treatment)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2027; primary completion for Dec 2028, 14 months later.

Of 14 phase 2 interventional studies under Gastroesophageal Reflux, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 14 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2024
First posted
Nov 25, 2024
StartEst.
Oct 1, 2027
Primary completionEst.
Dec 31, 2028
CompletionEst.
Mar 1, 2029
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06704100
Lead sponsor
Medical College of Wisconsin
Responsible party
Nikki Johnston (Professor, Medical College of Wisconsin) — Principal investigator
First posted
Nov 25, 2024
Start date
Oct 1, 2027 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Mar 1, 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

Ally Lesnick, BSc
Contact
alesnick@mcw.edu
414-955-2659
Nikki Johnston, PhD.
Contact
njohnston@mcw.edu
414-955-4075
Nikki Johnston, PhD.
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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