Heartburn and Acid Reflux Study
If you experience heartburn or acid reflux caused by gastroesophageal reflux disease (GERD), you may want to consider participating in this study.
GERD is a digestive disease caused by reflux of gastric acid or food into the esophagus. GERD is classified into erosive esophagitis (EE) and non-erosive reflux disease (NERD). Both can cause symptoms of heartburn and regurgitation. EE has changes in the esophageal lining whereas NERD has no changes. A diagnostic endoscopy is needed to make this determination. Untreated GERD can lead to complications such as bleeding, peptic strictures and could progress to cancer. This study will focus on EE.
GERD is predominantly by gastric acid suppressants such as Proton pump inhibitors (PPI) but up to 40% of patients experience incomplete response. A new class of medication is approved in other countries and being studies in the United States called Potassium-competitive blockers (P-CABs). The purpose of this study is to compare the safety and efficiency of a research P-CABs (tegoprazan) to a FDA approved medication, lansoprazole. This is a double-blind study meaning you nor will your research team know if you are taking tegoprazan or lansoprazole.
What Does this Study Require?
All participants will read and sign an Inform Consent prior to any study procedures. You will be asked to keep a diary of your heartburn and regurgitation episodes.
You will undergo a screening endoscopy to determine if you have any injury to your esophagus or other abnormalities. If you do have erosions you will be provided with two weeks of medication. You will have an additional endoscopy to determine if healing has occurred.
If so, we will be provided medication for 24 weeks (maintenance phase). However, if no healing occurs in week two, the healing phase will continue with an additional 6 weeks of medication followed by a third endoscopy.
If healed, you will continue on medication during a 24 week maintenance phase. All participants who complete the maintenance phase will have a final endoscopy.
Who Can Participate?
- 18 years of age or older
- Must be willing to undergo up to 4 endoscopies
- Basically healthy
- Not planning a hospitalization/surgical procedure
How to Learn More
You may call our office at 615-329-2222 and speak with our team or fill out the brief form above and we will reach out to you.
Our team will need to speak with you to determine your interest and to see if you qualify
The phone call will take about 10 minutes or less, and an appointment can be made to visit our office at 1500 Church St. There are no obligations if you inquire. There is no cost and compensation is provided to all participants and their families.
Potential Patient Benefits
All study related diagnostic tests and study medication are at no cost. Insurance is not required.
Compensation up to $2,050 may be provided for study participants.
Join Our Study
Please share your name and contact information so that we can speak with you about the study, answer any questions, and plan an initial visit.