Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06704100
PHASE2

Oral Fosamprenavir for GERD

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

50 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2027-10-01

Completion Date

2029-03-01

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

Fosamprenavir Calcium 700 MG Oral Tablet

1400 mg fosamprenavir BID

OTHER

Placebo

Placebo pill

Locations (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States