Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

Last updated: July 23, 2021
Sponsor: Ironwood Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Gastroparesis

Treatment

placebo

Standard-dose PPIs QD

IW-3718

Clinical Study ID

NCT03561883
C3718-302
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.

Eligibility Criteria

Inclusion

Inclusion Criteria: Each patient must meet all of the following criteria to be eligible for enrollment in thisstudy:

  • Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18years old at the Screening Visit.
  • Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn orregurgitation) 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 theduration of the study.
  • Patient must comply with study procedures.

Exclusion

Exclusion Criteria: Patients who meet any of the following criteria will not be eligible to participate in thestudy:

  • 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 wouldimpact drug absorption or metabolism (such as bowel obstruction, poorly controlleddiabetes, gastroparesis, hiatal hernia).
  • Patient reports pain or burning behind the breastbone or in the center of the upperstomach as his or her predominant symptom at the Screening Visit.
  • Patient has received an investigational drug during the 30 days before the ScreeningVisit, or is planning to receive another investigational drug or use aninvestigational device at any time during the study. NOTE: Other inclusion and exclusion criteria apply, per the study protocol.

Study Design

Total Participants: 609
Treatment Group(s): 3
Primary Treatment: placebo
Phase: 3
Study Start date:
September 06, 2018
Estimated Completion Date:
November 06, 2020

Connect with a study center

  • Hughie Fraser, MD

    Bridgewater, Nova Scotia B4V 3K9
    Canada

    Site Not Available

  • Viable Clinical Research

    Bridgewater, Nova Scotia B4V 3K9
    Canada

    Site Not Available

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Digestive Health Specialists of The Southeast

    Dothan, Alabama 36305
    United States

    Site Not Available

  • IW-3718 Research Site

    Huntsville, Alabama 35802
    United States

    Site Not Available

  • Holland Center for Family Health

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Hope Research Institute LLC

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Atria Clinical Research

    Little Rock, Arkansas 72209
    United States

    Site Not Available

  • Preferred Research Partners

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Hope Clinical Research, LLC

    Canoga Park, California 91303
    United States

    Site Not Available

  • Paragon Rx Clinical, Inc. - Santa Ana

    Garden Grove, California 92840
    United States

    Site Not Available

  • Om Research LLC

    Lancaster, California 93534
    United States

    Site Not Available

  • VA Loma Linda Healthcare System - NAVREF

    Loma Linda, California 92357
    United States

    Site Not Available

  • Torrance Clinical Research

    Lomita, California 90717
    United States

    Site Not Available

  • United Gastroenterologists

    Murrieta, California 92563
    United States

    Site Not Available

  • Clinical Applications Laboratories Inc

    San Diego, California 92103
    United States

    Site Not Available

  • Care Access Research, San Pablo

    San Pablo, California 94806
    United States

    Site Not Available

  • Paragon Rx Clinical, Inc. - Santa Ana

    Santa Ana, California 92703
    United States

    Site Not Available

  • Medical Research Center of Connecticut LLC

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Stamford Therapeutics Consortium

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Optimus U Corp

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • IW-3718 Research Site

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Nature Coast Clinical Research LLC - ERN-PPDS

    Inverness, Florida 34452
    United States

    Site Not Available

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Precision Clinical Research, LLC

    Lauderdale Lakes, Florida 33319
    United States

    Site Not Available

  • Applemed Research Inc

    Miami, Florida 33155
    United States

    Site Not Available

  • Suncoast Research Group LLC - ERN-PPDS

    Miami, Florida 33135
    United States

    Site Not Available

  • Gutierrez Medical Center

    Orlando, Florida 32807
    United States

    Site Not Available

  • Columbus Regional Research Institute at Talbotton

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Consultative Gastroenterology

    Decatur, Georgia 30034
    United States

    Site Not Available

  • IW-3718 Research Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Atlanta Center For Clinical Research

    Roswell, Georgia 30075
    United States

    Site Not Available

  • Clinical Research Atlanta - ERN-PPDS

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • IL Gastroenterology Group

    Gurnee, Illinois 60041
    United States

    Site Not Available

  • Edward Hines Jr VA Hospital - NAVREF

    Hines, Illinois 60141
    United States

    Site Not Available

  • Indiana University Health Physicians

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Aquiant Research

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Kansas Medical Clinic

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Heartland Research Associates LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • IW-3718 Research Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Gastroenterology Associates LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • IW-3718 Research Site

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Clinical Trials of America LA LLC

    West Monroe, Louisiana 71291
    United States

    Site Not Available

  • Investigative Clinical Research

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Centennial Medical Group

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • Commonwealth Clinical Studies LLC

    Brockton, Massachusetts 02302
    United States

    Site Not Available

  • Center For Digestive Health

    Troy, Michigan 48098
    United States

    Site Not Available

  • Gastroenterology Associates of West Michigan

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Gastrointestinal Associates PA

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Kansas City VA Medical Center - NAVREF

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Digestive Disease Specialists

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Office of Michael Zimmerman, MD

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • UHS Wilson Medical Center

    Binghamton, New York 13903
    United States

    Site Not Available

  • Advantage Clinical Trials

    Bronx, New York 10468
    United States

    Site Not Available

  • NYScientific

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York 11023
    United States

    Site Not Available

  • United Health Services Hospitals

    Johnson City, New York 13790
    United States

    Site Not Available

  • IW-3718 Research Site

    Orchard Park, New York 14127
    United States

    Site Not Available

  • NYScientific

    Queens Village, New York 11428
    United States

    Site Not Available

  • Syracuse VA Medical Center - NAVREF

    Syracuse, New York 13210
    United States

    Site Not Available

  • Asheville Gastroenterology Associates PA

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • UNC Medical Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • IW-3718 Research Site

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Carolina Digestive Diseases

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Clinical Trials of America-NC, LLC

    Mount Airy, North Carolina 27030
    United States

    Site Not Available

  • PMG Research of Salisbury LLC

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Trial Management Associates LLC

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Hightop Medical Research Center

    Cincinnati, Ohio 45224
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Remington Davis Inc

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Dayton Gastroenterology Inc

    Dayton, Ohio 45440
    United States

    Site Not Available

  • Prestige Clinical Research

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Lynn Health Science Institute - ERN-PPDS

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Northwest Gastroenterology Clinic

    Portland, Oregon 97210
    United States

    Site Not Available

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania 15243
    United States

    Site Not Available

  • Guthrie Research Institute

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Omega Medical Research

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Clinical Trials of South Carolina - ClinEdge - PPDS

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Pharmacorp Clinical Trials Incorporated

    Charleston, South Carolina 29412
    United States

    Site Not Available

  • Gastroenterology Associates, PA

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Coastal Carolina Research Center

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Clinical Trials of South Carolina

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Franklin Gastroenterology

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Clinical Research Solutions PC

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • QUALITY Medical Research - Interspond - PPDS

    Nashville, Tennessee 37211
    United States

    Site Not Available

  • Inquest Clinical Research

    Baytown, Texas 77521
    United States

    Site Not Available

  • Texas Health Physicians Group

    Carrollton, Texas 75007
    United States

    Site Not Available

  • Northside Gastroenterology

    Cypress, Texas 77429
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • Coastal Medical Group

    Houston, Texas 77089
    United States

    Site Not Available

  • Houston Endoscopy and Research Center

    Houston, Texas 77079
    United States

    Site Not Available

  • Kelsey Research Foundation

    Houston, Texas 77025
    United States

    Site Not Available

  • San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • IW-3718 Research Site

    Riverton, Utah 84065
    United States

    Site Not Available

  • Care Access Research

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • University of Utah Health Sciences Center

    Salt Lake City, Utah 84132-2101
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132-2101
    United States

    Site Not Available

  • Advanced Clinical Research - Gut Whisperer- ERN-PPDS

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Clinical Research Partners LLC

    Henrico, Virginia 23233
    United States

    Site Not Available

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • The Gastroenterology Group

    Reston, Virginia 22191
    United States

    Site Not Available

  • Clinical Research Partners LLC

    Richmond, Virginia 23220
    United States

    Site Not Available

  • Aurora Medical Center Summit

    Summit, Wisconsin 53066
    United States

    Site Not Available

  • Aurora Health Care

    Waukesha, Wisconsin 53186
    United States

    Site Not Available

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