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

Last updated: August 17, 2021
Sponsor: Ironwood Pharmaceuticals, Inc.
Overall Status: Terminated

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn

Gastroparesis

Treatment

N/A

Clinical Study ID

NCT03561090
C3718-301
  • 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: 495
Study Start date:
June 20, 2018
Estimated Completion Date:
November 03, 2020

Connect with a study center

  • ALTA Clinical Research Inc

    Edmonton, Alberta T5A 4L8
    Canada

    Site Not Available

  • Discovery Clincal Services Ltd

    Kelowna, British Columbia
    Canada

    Site Not Available

  • Taunton Surgical Centre

    Oshawa, Ontario L1H 3K4
    Canada

    Site Not Available

  • Digestive Health Clinic

    Richmond Hill, Ontario L4B 3P8
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • Recherche Clinique Sigma, Inc.

    Québec, G1G 3Y8
    Canada

    Site Not Available

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Alabama Medical Group, PC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Elite Clinical Studies

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Adobe Clinical Research LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Applied Research Center

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • Arkansas Gastroenterology

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Anaheim Clinical Trials LLC - ERN-PPDS

    Anaheim, California 92801
    United States

    Site Not Available

  • GW Research, Inc.

    Chula Vista, California 91910
    United States

    Site Not Available

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California 92879
    United States

    Site Not Available

  • Irvine Center For Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Facey Medical Foundation

    Mission Hills, California 91345
    United States

    Site Not Available

  • Northern California Research Corp

    Sacramento, California 95821
    United States

    Site Not Available

  • Digestive Care Center

    San Carlos, California 94070
    United States

    Site Not Available

  • Medical Associates Research Group, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Precision Research Institute

    San Diego, California 92114
    United States

    Site Not Available

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • Chase Medical Research LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • West Central Gastroenterology, LLP

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Avail Clinical Research LLC

    DeLand, Florida 32720
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • IW-3718 Research Site

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Borland Groover Clinic

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Health Awareness Inc - MRA

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Millennium Clinical Research Inc-Miami

    Miami, Florida 33125
    United States

    Site Not Available

  • Advanced Research Institute, Inc

    New Port Richey, Florida 34653
    United States

    Site Not Available

  • Legacy Clinical Solutions: Sensible HealthCare, LLC - BTC - PPDS

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Pines Clinical Research Inc

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • DMI Research

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Palm Beach Research Center

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Atlanta Center For Gastroenterology PC

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia 31201
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Avicenna-DM Clinical Research

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Iowa Digestive Disease Center

    Clive, Iowa 50325
    United States

    Site Not Available

  • West Glen GI

    Shawnee Mission, Kansas 66217
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • CroNOLA, LLC.

    Houma, Louisiana 70360
    United States

    Site Not Available

  • Clinical Trials Management LLC

    Mandeville, Louisiana 70471
    United States

    Site Not Available

  • Tandem Clinical Research, LLC

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Alan A Rosen MD PA

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Elligo Health Research

    Frederick, Maryland 21701
    United States

    Site Not Available

  • Meritus Center For Clinical Research

    Hagerstown, Maryland 21742
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Huron Gastroenterology Associates,P.C.

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63141
    United States

    Site Not Available

  • Kansas City Gastroenterology and Hepatology

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Clinical Research Professionals

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Advanced Research Institute - Reno

    Reno, Nevada 89511
    United States

    Site Not Available

  • AGA Clinical Research Associates, LLC. - MRA

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • Lovelace Scientific Resources Inc

    Albuquerque, New Mexico 87108
    United States

    Site Not Available

  • NYU School of Medicine

    Great Neck, New York 11021
    United States

    Site Not Available

  • IMA Medical Research, PC.

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • Manhattan Medical Research Practice PLLC

    New York, New York 10016
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Site Not Available

  • Orchard Park Family Practice

    Orchard Park, New York 14127
    United States

    Site Not Available

  • IW-3718 Research Site

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Fayetteville Gastroenterology Associates PA

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Medication Management LLC

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • Peters Medical Research, LLC

    High Point, North Carolina 27262
    United States

    Site Not Available

  • East Carolina Gastroenterology

    Jacksonville, North Carolina 28546
    United States

    Site Not Available

  • Wake Endoscopy Center

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Wake Research Associates, LLC

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Aventiv Research, Inc.

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Legacy Research Institute

    Portland, Oregon 97232
    United States

    Site Not Available

  • Family Medical Associates

    Levittown, Pennsylvania 19056
    United States

    Site Not Available

  • Veterans Research Foundation of Pittsburgh - NAVREF

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

  • Consultants of Gastroenterology

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • WR - ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Multi Specialty Clinical Research

    Johnson City, Tennessee 37601
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Advanced Gastroenterology-Union City

    Union City, Tennessee 38237
    United States

    Site Not Available

  • Dallas VA Medical Center - NAVREF

    Dallas, Texas 75231
    United States

    Site Not Available

  • Digestive Health Associates of Texas

    Garland, Texas 75044
    United States

    Site Not Available

  • Biopharma Informatic Inc.

    Houston, Texas 77043
    United States

    Site Not Available

  • Houston Digestive Diseases Clinic

    Houston, Texas 77090
    United States

    Site Not Available

  • Research Consultants

    Houston, Texas 77084
    United States

    Site Not Available

  • Southwest Clinical Trials

    Houston, Texas 77074
    United States

    Site Not Available

  • Pearland Physicians

    Pearland, Texas 77581
    United States

    Site Not Available

  • Quality Research Inc

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Texas Digestive Disease Consultants

    Southlake, Texas 76092
    United States

    Site Not Available

  • Avicenna-DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • Aspen Clinical Research LLC - MRA

    Orem, Utah 84058
    United States

    Site Not Available

  • New River Valley Research Institute

    Christiansburg, Virginia 24073
    United States

    Site Not Available

  • GI Associates Gainesville

    Gainesville, Virginia 20155
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Washington Gastroenterology

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Wisconsin Center for Advanced Research Division of GI Associates

    Brookfield, Wisconsin 53005
    United States

    Site Not Available

  • Mayo Clinic Health System - Franciscan Healthcare - PPDS

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • Wisconsin Center for Advanced Research Division of GI Associates

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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