Oral Fosamprenavir + Sodium Alginate for GERD

Launched by MEDICAL COLLEGE OF WISCONSIN · Nov 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people who have persistent symptoms of gastroesophageal reflux disease (GERD) that don't get better with standard medication called proton pump inhibitors (PPIs). The study drug being tested is a combination of Fosamprenavir and Sodium Alginate (FOS-SA). Researchers want to find out if this new treatment can help reduce heartburn and regurgitation symptoms over an 8-week period compared to a placebo, which is a look-alike pill that contains no active medication.

To participate in the trial, you must be between 18 and 65 years old and have been experiencing GERD symptoms despite taking PPIs for at least 8 weeks. You will need to visit the research center seven times for check-ups and tests and keep a daily diary of your symptoms. This study is currently not recruiting participants, but it aims to help improve treatment options for those struggling with ongoing GERD symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient aged 18-65 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).