A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
Gastroesophageal Reflux Disease (GERD)
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal Reflux Disease, GERD, Proton Pump Inhibitors, IW-3718
Eligibility Criteria
Inclusion Criteria:
Each patient must meet all of the following criteria to be eligible for enrollment in this study:
- Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit.
- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy.
- Patient has evidence of pathological acid reflux.
- Female patients must not be pregnant and must agree to avoid pregnancy for the duration of the study.
- Patient must comply with study procedures.
Exclusion Criteria:
Patients who meet any of the following criteria will not be eligible to participate in the study:
- Patient has a history of complete lack of GERD symptom response to PPI therapy.
- Patient has a significant medical or surgical history including conditions that would impact drug absorption or metabolism (such as bowel obstruction, poorly controlled diabetes, gastroparesis, hiatal hernia).
- Patient reports pain or burning behind the breastbone or in the center of the upper stomach as his or her predominant symptom at the Screening Visit.
- Patient has received an investigational drug during the 30 days before the Screening Visit, or is planning to receive another investigational drug or use an investigational device at any time during the study.
NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
Sites / Locations
- Pinnacle Research Group
- Alabama Medical Group, PC
- Elite Clinical Studies
- Adobe Clinical Research LLC
- Applied Research Center
- Arkansas Gastroenterology
- Anaheim Clinical Trials LLC - ERN-PPDS
- GW Research, Inc.
- Kindred Medical Institute for Clinical Trials, LLC
- Facey Medical Foundation
- Northern California Research Corp
- Digestive Care Center
- Precision Research Institute
- Medical Associates Research Group, Inc.
- Stanford University School of Medicine
- University of Colorado Hospital
- Gastroenterology Associates of Fairfield County
- Connecticut Clinical Research Foundation
- Chase Medical Research LLC
- West Central Gastroenterology, LLP
- Avail Clinical Research LLC
- University of Florida
- Mayo Clinic Jacksonville - PPDS
- Borland Groover Clinic
- Health Awareness Inc - MRA
- Millennium Clinical Research Inc-Miami
- Advanced Research Institute, Inc
- Legacy Clinical Solutions: Sensible HealthCare, LLC - BTC - PPDS
- Advanced Gastroenterology Associates, LLC
- Pines Clinical Research Inc
- DMI Research
- Palm Beach Research Center
- Atlanta Center For Gastroenterology PC
- Gastroenterology Associates of Central Georgia, LLC
- Avicenna-DM Clinical Research
- Iowa Digestive Disease Center
- West Glen GI
- Cotton O'Neil Clinical Research Center
- CroNOLA, LLC.
- Clinical Trials Management LLC
- Tandem Clinical Research, LLC
- Alan A Rosen MD PA
- Elligo Health Research
- Meritus Center For Clinical Research
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Clinical Research Institute of Michigan
- Minnesota Gastroenterology, P.A.
- Clinical Research Professionals
- Kansas City Gastroenterology and Hepatology
- Advanced Research Institute - Reno
- AGA Clinical Research Associates, LLC. - MRA
- Lovelace Scientific Resources Inc
- NYU School of Medicine
- Beth Israel Medical Center
- Manhattan Medical Research Practice PLLC
- Weill Cornell Medical College
- Orchard Park Family Practice
- Medication Management LLC
- Peters Medical Research, LLC
- East Carolina Gastroenterology
- Wake Endoscopy Center
- Wake Research Associates, LLC
- Consultants For Clinical Research Inc
- Cleveland Clinic
- Aventiv Research, Inc.
- Great Lakes Gastroenterology Research, LLC
- Digestive Disease Specialists, Inc.
- Legacy Research Institute
- Veterans Research Foundation of Pittsburgh - NAVREF
- Consultants of Gastroenterology
- WR - ClinSearch, LLC
- Gastro One
- Multi Specialty Clinical Research
- Vanderbilt University Medical Center
- Advanced Gastroenterology-Union City
- Dallas VA Medical Center - NAVREF
- Digestive Health Associates of Texas
- Biopharma Informatic Inc.
- Southwest Clinical Trials
- Research Consultants
- Houston Digestive Diseases Clinic
- Pearland Physicians
- Quality Research Inc
- Texas Digestive Disease Consultants
- Advanced Research Institute
- Aspen Clinical Research LLC - MRA
- New River Valley Research Institute
- GI Associates Gainesville
- Blue Ridge Medical Research
- Washington Gastroenterology
- Mayo Clinic Health System - Franciscan Healthcare - PPDS
- Wisconsin Center for Advanced Research Division of GI Associates
- ALTA Clinical Research Inc
- Taunton Surgical Centre
- Digestive Health Clinic
- Sunnybrook Health Sciences Centre
- Toronto Digestive Disease Associates Inc
- Recherche Clinique Sigma, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1500 mg IW-3718 BID + PPI
Placebo + PPI
Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.
Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.