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Study for Reflux Patients Not Responding to Medications

This is a clinical trial to evaluate the safety and effectiveness of an investigational drug designed for patients with Gastroesophageal Reflux Disease (GERD) who are still experiencing symptoms while on Proton Pump Inhibitors (PPIs). Participants will be randomized to receive study medication or a placebo while continuing to take daily PPI medication.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will make regular visits to our clinic for about 17 weeks (5 visits total). While in the study, you will be randomized to receive the investigational medication or placebo for up to 8 weeks. You will be able to continue taking your current PPI reflux medication during the study. During your visits, the study staff will perform study-related tests and assessments (e.g. physical exam, blood draw, pregnancy tests and urine screening) to see how you're responding to the study medication. The study also requires completion of questionnaires about your symptoms throughout your participation.

Incentives

Up to $1,050.00

In-person visits : 5
Phone or online visits : 1
Total length of participation : 17 weeks

Looking for Specific Volunteers

Able to participate:

  • Current diagnosis of Gastroesophageal Reflux Disease (GERD)
  • Must have experienced GERD symptoms (heartburn or regurgitation) for an average of 4 or more days per week over the past 8 weeks
  • Must be currently receiving a once daily standard (label) dose of Proton Pump Inhibitor (PPI) medication for a minimum of 8 weeks
  • Must have a history of persistent GERD symptoms despite receiving PPI therapy
  • Female patients must be postmenopausal for at least 1 year, surgically sterile or must agree to use a highly effective contraception throughout the trial

Not eligible if:

  • History of complete lack of GERD symptom response to PPIs
  • Active swallowing disorder that would affect ability to swallow medications
  • History of a major GI surgery
  • Non-GI surgery of the abdomen, pelvis, pancreas, uterus, colon, kidneys, esophagus or rectum during the last 6 months
  • Diagnosis of Gilbert's disease, Crohn's disease' diabetes mellitus(poorly controlled), Zollinger-Ellison syndrome, pancreatitis, cholecystitis, or systemic sclerosis

Contact the Team

Visit Location

100% Remote (online, phone, text)

Additional Study Information

Principal Investigator

Nicholas Shaheen
Medicine-Gastroenterology

Study Type

Clinical or Medical
Interventional

Study Topics

Aging
Stomach, Digestion and Gut Health
Ear, Nose, and Throat
Eating, Nutrition, and Metabolism
Obesity
Pain
Sleep
Substance Use (tobacco, alcohol, opioids, etc)
Women's Health
Men's Health

IRB Number

18-2776

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