Refractory Gastroesophageal Reflux DiseasePhase 2NCT06704100
Oral Fosamprenavir for GERD
A Phase 2 study testing Fosamprenavir Calcium 700 MG Oral Tablet in people with Refractory Gastroesophageal Reflux Disease and Gastroesophageal Reflux Disease, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Refractory Gastroesophageal Reflux Disease, Gastroesophageal Reflux Disease
- What is being tested?
- Fosamprenavir Calcium 700 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2027to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 50-65 selected as candidate for anti-reflux surgery by study providers.
- 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.
- 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:
- Erosive esophagitis (Grade A or greater based on the Los Angeles classification of esophagitis; Appendix 3)
- 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
- 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.
Who cannot join
- Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4.
- Patient has endoscopically confirmed eosinophilic esophagitis (EE).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Ally Lesnick, BSc., 414-955-2659, alesnick@mcw.edu
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir Administered Orally for 8 Weeks in Older Adults With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease
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:
Read more
- Does fosamprenavir significantly improve heartburn severity over the 8-week treatment period
- Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period
- 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:
- Take fosamprenavir or placebo every day BID (twice a day) for 8 weeks
- Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests
- Keep a daily diary of their symptoms of persistent GERD
- Being tested
- Fosamprenavir Calcium 700 MG Oral Tablet, Placebo
- Keywords
- PPI-refractory GERD, Proton pump inhibitor refractory gastroesophageal reflux disease, Fosamprenavir
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosamprenavir Calcium 700 MG Oral TabletDrug
1400 mg fosamprenavir BID
PlaceboOther
Placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Oral Fosamprenavir | Experimental | 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 Receives: Drug: Fosamprenavir Calcium 700 MG Oral Tablet |
| Oral Placebo | Placebo comparator | Eight weeks of:
Placebo Pill Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Treatment Week 8 (End of Treatment)
Secondary outcomes (3)
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.
Measured: Baseline to Treatment Week 8 (End of Treatment)
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.
Measured: Baseline to Treatment Week 8 (End of Treatment)
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.
Measured: Baseline to Treatment Week 8 (End of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Oct 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Proof-of-Concept
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikki Johnston, Medical College of Wisconsin
- Investigators
- Nikki Johnston, PhD., Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704100
- Sponsor's protocol ID
- PRO000000000
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir Administered Orally for 8 Weeks in Older Adults With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT06704100
- Acronym / sponsor ID
- PRO000000000
- Keywords
- PPI-refractory GERD, Proton pump inhibitor refractory gastroesophageal reflux disease, Fosamprenavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Oct 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does fosamprenavir significantly improve heartburn severity over the 8-week treatment period
- Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period
- 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:
- Take fosamprenavir or placebo every day BID (twice a day) for 8 weeks
- Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests
- Keep a daily diary of their symptoms of persistent GERD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Proof-of-Concept
| Arm | Type | Receives |
|---|---|---|
| Oral Fosamprenavir | Experimental | Drug: Fosamprenavir Calcium 700 MG Oral TabletEight weeks of: 1400 mg fosamprenavir BID: At least 1 hour before or 2 hours after the morning and evening meals, approximately 12 hours apart |
| Oral Placebo | Placebo comparator | Other: PlaceboEight weeks of: Placebo Pill |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 50-65 selected as candidate for anti-reflux surgery by study providers.
- 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.
- 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:
- 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.
Key exclusion criteria (2 listed)
- Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4.
- Patient has endoscopically confirmed eosinophilic esophagitis (EE).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosamprenavir Calcium 700 MG Oral Tablet1400 mg fosamprenavir BID | Drug | Oral Fosamprenavir |
| PlaceboPlacebo pill | Other | Oral Placebo |
Primary outcome
Weekly Heartburn Severity Score
Time frame: Baseline to Treatment Week 8 (End of Treatment)
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)
3 secondary outcomes
Weekly Regurgitation Frequency Score
Time frame: Baseline to Treatment Week 8 (End of Treatment)
Weekly Heartburn-free Days
Time frame: Baseline to Treatment Week 8 (End of Treatment)
Weekly Overall Reflux Symptom-free Days
Time frame: Baseline to Treatment Week 8 (End of Treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Refractory Gastroesophageal Reflux Disease
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Endoscopic Injection of Autologous Fat-Derived Cells (SVF) for Adults With Refractory Gastroesophageal Reflux Disease (GERD). (The GERD-REVIVE Pilot Study)
GERD (Gastroesophageal Reflux Disease)
Recruiting
Compassionate Use of Domperidone for Refractory Gastroparesis
GERD, Gastroesophageal Reflux
Enrolling by invitation
Vonoprazan Test for PPI Refractory GERD
Refractory GERD, NERD
RecruitingPhase 2
Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough
Refractory Chronic Cough
Not yet recruiting
Endoscopic Cardial Constriction Ligation (ECCL) for Refractory GERD Using a Disposable Endoscope
Gastroesophageal Reflux Disease (GERD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikki Johnston, PhD. principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosamprenavir Calcium 700 MG Oral Tablet in people with Refractory Gastroesophageal Reflux Disease and Gastroesophageal Reflux Disease, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ally Lesnick, BSc (414-955-2659, alesnick@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Heartburn Severity Score (time frame: Baseline to Treatment Week 8 (End of Treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.