Heartburn/Acid Reflux Clinical Trial:

Compensation between $1100 - $2050

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Clinical Study for Heartburn/Acid Reflux Treatments

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Do you have erosive or non-erosive esophagitis?
How would you describe yourself?*
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Study 1) Erosive Esophagitis (EE)

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.

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

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

Study 2) Non-Erosive Gastroesophageal Reflux Disease (NERD)

NERD is a common condition that develops when the contents of the stomach flow back into the esophagus causing troublesome heartburn.  Over time irritation and inflammation from the acid can injure the esophagus.  A diagnostic endoscopic examination can determine if there has been injury to the esophagus.

Despite the availability of prescription and over-the-counter medications, the management of heartburn can be a problem.  About 40% of heartburn suffers report continued symptoms after treatment.

The purpose of this study is to determine the safety and efficacy of a research medication compared to a placebo. The research medication is approved in other countries but not FDA approved in the United States.  Each participant will undergo an endoscopic exam (EDG) and will participate in two phases of study.  All participants will receive 4 weeks of active treatment or placebo followed by an extension period of 20 weeks of active research medication.

What does this study involve?

All participants will read and sign an inform Consent Form (ICF) and keep an electronic diary to record episodes of heartburn. If you qualify for the study, you will undergo a screening EGD.  If there are no injury to your esophagus (Erosions) or other abnormalities, you will be provided with study medication and continue keeping a diary.  There are 9 visits to our office over approximately 28 weeks. Study medication, laboratory, diagnostic testing and other study related procedures are at no charge.

Compensation is up to $1100.

Who qualifies?

  • 18 years of age or older
  • Must be willing to undergo an Endoscopic exam
  • Basically healthy with no active ulcers or GI bleeding in prior 30 days
  • Not planning a hospitalization or surgical procedure

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