Erosive Esophagitis Clinical Study

Erosive Esophagitis

Gastroesophageal reflux disease (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. To read about our NERD study, click here.

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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 involve?

All participants will read and sign an Inform Consent prior to any study procedures.  You will be ask 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 at week two, the healing phase will continue with an additional 6 weeks of medication followed by a third endoscopy.  If healed continue on medication during a 24 week maintenance phase.  All participants who complete the maintenance phase will have a final endoscopy.

All study related procedures and medication will be provided at no charge.  No insurance needed as it will not be billed.

Compensation up to $2050

Clinical Study for Heartburn Treatments

MM slash DD slash YYYY
Do you have erosive or non-erosive esophagitis?
How would you describe yourself?*
*Please check all that apply.
Are you willing to share information about this study with interested friends and family members?
Word of mouth helps improve enrollment, thus reducing the time and cost to research the vaccine.
This field is for validation purposes and should be left unchanged.

About the Study

The purpose of this study is to determine the safety and efficacy of a research medication in the treatment of heartburn.  This medication is approved in several countries but not FDA approved for use in the United States.  Each participant will undergo an endoscopic exam (EDG) and  will participate in two phases of the study. All participants will receive 4 weeks of active treatment or placebo followed by 20 weeks of active treatment during the long term phase of the study.

Who qualifies?

Who qualifies?

*18 years of age or older

*Must be willing to undergo up to 4 endoscopies

*Basically healthy

*Not planning a hospitalization/surgical procedure

For more information and to see if you may be eligible to participate, call 615-329-2222 or fill out our pre-screening form below.