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Phase 3 study for patients with GERD - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study drug (IW-3718) is safe and will work in reducing gastroesophageal reflux symptoms when you are still taking your proton pump inhibitor medicine.

What is the Condition Being Studied?

GERD

Who Can Participate in the Study?

Adults who:
- Are currently taking a proton pump inhibitor medication (PPI) and still experiencing reflux/GERD symptoms at least 4 times a week
- Are willing to undergo an EGD and Bravo placement

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have an ECG
- Have several blood and urine tests including a drug screen
- Have a physical exam
- Have a esophogastroduodenoscopy (EGD: a scope that is placed to see inside your esophagus and stomach) with Bravo capsule placement that will record your stomach acid levels
- Complete questionnaires

Study Details

Full Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors
Principal Investigator
Gastroenterologist
Protocol Number
IRB:PRO00100236
NCT:NCT03561883
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698