A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
NCT ID: NCT03561090
Last Updated: 2021-08-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
495 participants
INTERVENTIONAL
2018-06-20
2020-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1500 mg IW-3718 BID + 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.
IW-3718
oral tablet
Standard-dose PPIs QD
background therapy
Placebo + PPI
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.
placebo
oral tablet
Standard-dose PPIs QD
background therapy
Interventions
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IW-3718
oral tablet
placebo
oral tablet
Standard-dose PPIs QD
background therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mike Shetzline, MD, PhD
Role: STUDY_CHAIR
Chief Medical Officer
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Alabama Medical Group, PC
Mobile, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Adobe Clinical Research LLC
Tucson, Arizona, United States
Applied Research Center
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Anaheim Clinical Trials LLC - ERN-PPDS
Anaheim, California, United States
GW Research, Inc.
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Northern California Research Corp
Sacramento, California, United States
Digestive Care Center
San Carlos, California, United States
Precision Research Institute
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Stanford University School of Medicine
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
West Central Gastroenterology, LLP
Clearwater, Florida, United States
Avail Clinical Research LLC
DeLand, Florida, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
Borland Groover Clinic
Jacksonville, Florida, United States
Health Awareness Inc - MRA
Jupiter, Florida, United States
Millennium Clinical Research Inc-Miami
Miami, Florida, United States
Advanced Research Institute, Inc
New Port Richey, Florida, United States
Legacy Clinical Solutions: Sensible HealthCare, LLC - BTC - PPDS
Ocoee, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Pines Clinical Research Inc
Pembroke Pines, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Atlanta Center For Gastroenterology PC
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
Avicenna-DM Clinical Research
Oak Lawn, Illinois, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
West Glen GI
Shawnee Mission, Kansas, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
CroNOLA, LLC.
Houma, Louisiana, United States
Clinical Trials Management LLC
Mandeville, Louisiana, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
Alan A Rosen MD PA
Baltimore, Maryland, United States
Elligo Health Research
Frederick, Maryland, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
Advanced Research Institute - Reno
Reno, Nevada, United States
AGA Clinical Research Associates, LLC. - MRA
Egg Harbor, New Jersey, United States
Lovelace Scientific Resources Inc
Albuquerque, New Mexico, United States
NYU School of Medicine
Great Neck, New York, United States
Beth Israel Medical Center
New York, New York, United States
Manhattan Medical Research Practice PLLC
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Orchard Park Family Practice
Orchard Park, New York, United States
Medication Management LLC
Greensboro, North Carolina, United States
Peters Medical Research, LLC
High Point, North Carolina, United States
East Carolina Gastroenterology
Jacksonville, North Carolina, United States
Wake Endoscopy Center
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Consultants For Clinical Research Inc
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States
Legacy Research Institute
Portland, Oregon, United States
Veterans Research Foundation of Pittsburgh - NAVREF
Pittsburgh, Pennsylvania, United States
Consultants of Gastroenterology
Columbia, South Carolina, United States
WR - ClinSearch, LLC
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Multi Specialty Clinical Research
Johnson City, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Advanced Gastroenterology-Union City
Union City, Tennessee, United States
Dallas VA Medical Center - NAVREF
Dallas, Texas, United States
Digestive Health Associates of Texas
Garland, Texas, United States
Biopharma Informatic Inc.
Houston, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
Research Consultants
Houston, Texas, United States
Houston Digestive Diseases Clinic
Houston, Texas, United States
Pearland Physicians
Pearland, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Aspen Clinical Research LLC - MRA
Orem, Utah, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
GI Associates Gainesville
Gainesville, Virginia, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Mayo Clinic Health System - Franciscan Healthcare - PPDS
La Crosse, Wisconsin, United States
Wisconsin Center for Advanced Research Division of GI Associates
Milwaukee, Wisconsin, United States
ALTA Clinical Research Inc
Edmonton, Alberta, Canada
Taunton Surgical Centre
Oshawa, Ontario, Canada
Digestive Health Clinic
Richmond Hill, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Digestive Disease Associates Inc
Vaughan, Ontario, Canada
Recherche Clinique Sigma, Inc.
Québec, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C3718-301
Identifier Type: -
Identifier Source: org_study_id
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