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Study for Reflux Patients Not Responding to Medications

University of North Carolina at Chapel Hill


Description

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.


Keywords:

Digestion, Elderly, Men's Health, Mouth/Nose/Throat, Nutrition, Obesity, Older Adults, Pain, Smoking, Stomach, Women's Health, Sleep


Category:

Drug or Biologic
Phase:3

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

Adult patients with diagnosed GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once daily PPI therapy.


Investigator

Nicholas Shaheen
Distinguished Professor
Medicine-Gastroenterology

For questions, contact:

Yaa Ofori-Marfoh
yaa_ofori-marfoh@med.unc.edu
(919) 843-5884


Recruitment Period End

January 1, 2020

Location

Primary Location
Clinical & Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA
Secondary Location
UNC Hilsborough Endoscopy Center
430 Waterstone Dr, Hillsborough, NC 27278, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) - 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 daily 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 - History of pancreatitis due to high triglycerides - Diagnosis of gastroparesis or history of bowel obstruction - Diagnosis of Gilbert's disease, Crohn's disease' diabeties mellitus, Zollinger-Ellison syndrome, pancreatitis, cholecystitis, or systemic sclerosis

Number of Visits

    » 5 In person visit(s)

    1 screening, 4 Clinic,

    » 1 Remote visit(s)

    1 phone

Participation Period

10 weeks

Compensation

$1050.00

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.