Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT06704100
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
Trial opening soon.
Get Notified18 year–64 year
All sexes
Interventional
Phase 2
Milwaukee, Wisconsin, 53226, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1400 mg FOS-SA BID: 15 ml oral solution containing 1400 mg fosamprenavir calcium and 24.5 mg sodium alginate administered BID
15 ml oral solution containing 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate
Other names: Microcrystalline cellulose, Sodium Alginate
Time frame: Ten days of pre-screening and dailyfor 8 weeks.
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]
Time frame: Ten days of pre-screening and daily for 8 weeks.
Based on questions 7 and 7 of mRESQ-eD. The percent change from baseline (i.e., Pretreatment) in regurgitation frequency as indicated by Weekly Regurgitation Frequency Score (WRFS) at Week 8. Weekly scoring averaged.
[Minimum Value: 0, Maximum Value: 400, higher score= worse outcome]
Time frame: Ten days of pre-screening and daily for 8 weeks.
The percent change from baseline (i.e., Pretreatment) in symptoms of persistent GERD as indicated by mRESQ-eD weekly total GERD score (WTGS) at Week 8. Weekly scoring averaged.
[Minimum Value: 0, Maximum Value: 1850, higher score= worse outcome]
Contact information is provided by the study sponsor or research team.
Ally Lesnick, BSc
CONTACT
Nikki Johnston, PhD.
CONTACT
Medical College of Wisconsin
Other
A Phase 2, Randomized, Double-blind, Placebo-controlled Trial of Fosamprenavir-Sodium Alginate Administered Orally for 8 Weeks to Patients With Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07667894
Deglutition Disorders, Digestive System Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT04763993
Body Weight, Deglutition Disorders
View Trial DetailsNCT07049315
Apnea, Deglutition Disorders
Curitiba, Paraná, Brazil
View Trial DetailsNCT07036627
Deglutition Disorders, Digestive System Diseases
Bari, Italy
View Trial Details