Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
NCT ID: NCT03561883
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
609 participants
INTERVENTIONAL
2018-09-06
2020-11-06
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
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
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
Ironwood Pharmaceuticals, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Digestive Health Specialists of The Southeast
Dothan, Alabama, United States
Holland Center for Family Health
Peoria, Arizona, United States
Hope Research Institute LLC
Peoria, Arizona, United States
Atria Clinical Research
Little Rock, Arkansas, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Hope Clinical Research, LLC
Canoga Park, California, United States
Om Research LLC
Lancaster, California, United States
Torrance Clinical Research
Lomita, California, United States
United Gastroenterologists
Murrieta, California, United States
Clinical Applications Laboratories Inc
San Diego, California, United States
Care Access Research, San Pablo
San Pablo, California, United States
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, United States
Medical Research Center of Connecticut LLC
Hamden, Connecticut, United States
Yale School of Medicine
New Haven, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Optimus U Corp
Coral Gables, Florida, United States
Nature Coast Clinical Research LLC - ERN-PPDS
Inverness, Florida, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States
Precision Clinical Research, LLC
Lauderdale Lakes, Florida, United States
Suncoast Research Group LLC - ERN-PPDS
Miami, Florida, United States
Applemed Research Inc
Miami, Florida, United States
Gutierrez Medical Center
Orlando, Florida, United States
Columbus Regional Research Institute at Talbotton
Columbus, Georgia, United States
Consultative Gastroenterology
Decatur, Georgia, United States
Atlanta Center For Clinical Research
Roswell, Georgia, United States
Clinical Research Atlanta - ERN-PPDS
Stockbridge, Georgia, United States
IL Gastroenterology Group
Gurnee, Illinois, United States
Edward Hines Jr VA Hospital - NAVREF
Hines, Illinois, United States
Aquiant Research
New Albany, Indiana, United States
Kansas Medical Clinic
Topeka, Kansas, United States
Heartland Research Associates LLC
Wichita, Kansas, United States
Gastroenterology Associates LLC
Baton Rouge, Louisiana, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, United States
Clinical Trials of America LA LLC
West Monroe, Louisiana, United States
Investigative Clinical Research
Annapolis, Maryland, United States
Centennial Medical Group
Elkridge, Maryland, United States
Commonwealth Clinical Studies LLC
Brockton, Massachusetts, United States
Center For Digestive Health
Troy, Michigan, United States
Gastroenterology Associates of West Michigan
Wyoming, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC
Wyoming, Michigan, United States
Gastrointestinal Associates PA
Flowood, Mississippi, United States
Kansas City VA Medical Center - NAVREF
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Digestive Disease Specialists
Las Vegas, Nevada, United States
Office of Michael Zimmerman, MD
Las Vegas, Nevada, United States
Morristown Medical Center
Morristown, New Jersey, United States
NYScientific
Brooklyn, New York, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States
United Health Services Hospitals
Johnson City, New York, United States
Syracuse VA Medical Center - NAVREF
Syracuse, New York, United States
Advantage Clinical Trials
The Bronx, New York, United States
Asheville Gastroenterology Associates PA
Asheville, North Carolina, United States
UNC Medical Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolina Digestive Diseases
Greenville, North Carolina, United States
Clinical Trials of America-NC, LLC
Mount Airy, North Carolina, United States
PMG Research of Salisbury LLC
Salisbury, North Carolina, United States
Trial Management Associates LLC
Wilmington, North Carolina, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Remington Davis Inc
Columbus, Ohio, United States
Dayton Gastroenterology Inc
Dayton, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute - ERN-PPDS
Oklahoma City, Oklahoma, United States
Northwest Gastroenterology Clinic
Portland, Oregon, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Guthrie Research Institute
Sayre, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Clinical Trials of South Carolina - ClinEdge - PPDS
Charleston, South Carolina, United States
Pharmacorp Clinical Trials Incorporated
Charleston, South Carolina, United States
Gastroenterology Associates, PA
Greenville, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Trials of South Carolina
North Charleston, South Carolina, United States
Franklin Gastroenterology
Franklin, Tennessee, United States
Clinical Research Solutions PC
Jackson, Tennessee, United States
QUALITY Medical Research - Interspond - PPDS
Nashville, Tennessee, United States
Inquest Clinical Research
Baytown, Texas, United States
Texas Health Physicians Group
Carrollton, Texas, United States
Northside Gastroenterology
Cypress, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Kelsey Research Foundation
Houston, Texas, United States
Houston Endoscopy and Research Center
Houston, Texas, United States
Coastal Medical Group
Houston, Texas, United States
San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
San Antonio, Texas, United States
Care Access Research
Salt Lake City, Utah, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Advanced Clinical Research - Gut Whisperer- ERN-PPDS
West Jordan, Utah, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
The Gastroenterology Group
Reston, Virginia, United States
Clinical Research Partners LLC
Richmond, Virginia, United States
Clinical Research Partners LLC
Richmond, Virginia, United States
Aurora Medical Center Summit
Summit, Wisconsin, United States
Aurora Health Care
Waukesha, Wisconsin, United States
Hughie Fraser, MD
Bridgewater, Nova Scotia, Canada
Viable Clinical Research
Bridgewater, Nova Scotia, Canada
Toronto Digestive Disease Associates Inc
Vaughan, Ontario, 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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C3718-302
Identifier Type: -
Identifier Source: org_study_id
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