Gastroesophageal Reflux Disease, Refractory Gastroesophageal Reflux Disease
Conditions
Keywords
PPI-refractory GERD, Proton pump inhibitor refractory gastroesophageal reflux disease, Fosamprenavir
Brief 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
Interventions
DRUGFosamprenavir Calcium 700 MG Oral Tablet
1400 mg fosamprenavir BID
OTHERPlacebo
Placebo pill
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
We have partnered with Froedtert Hospital's Investigative Drug Services (FH IDS) in order to randomize subjects to either treatment or placebo. Only FH IDS will have the key linking subjects to treatment groups, and the power to conduct an emergency un-blinding.
Intervention model description
Proof-of-Concept
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
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
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Heartburn Severity Score | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Regurgitation Frequency Score | Baseline to Treatment Week 8 (End of Treatment) | 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. |
| Weekly Heartburn-free Days | Baseline to Treatment Week 8 (End of Treatment) | 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. |
| Weekly Overall Reflux Symptom-free Days | Baseline to Treatment Week 8 (End of Treatment) | 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. |
Countries
United States
Contacts
CONTACTAlly Lesnick, BSc
CONTACTNikki Johnston, PhD.
PRINCIPAL_INVESTIGATORNikki Johnston, PhD.
Medical College of Wisconsin
Outcome results
None listed