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

NCT03561090 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: C3718-301
• Study Type: interventional
• Target: 495
• Locations: 2 countries
• Sites: 99

Brief 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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Gastroesophageal Reflux Disease; GERD; Proton Pump Inhibitors; IW-3718

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in WHSS at Week 8

  The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement.

  Baseline, Week 8

Secondary Outcomes (3)

• Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8

  Baseline, Week 8

• Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period

  Up to Week 8

• Proportion of Heartburn-Free Days During the 8-Week Treatment Period

  Up to Week 8

Study Arms (2)

1500 mg IW-3718 BID + PPI

EXPERIMENTAL

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.

Drug: IW-3718; Drug: Standard-dose PPIs QD

Placebo + PPI

PLACEBO COMPARATOR

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.

Drug: placebo; Drug: Standard-dose PPIs QD

Interventions

IW-3718 DRUG

oral tablet

1500 mg IW-3718 BID + PPI

placebo DRUG

oral tablet

Placebo + PPI

Standard-dose PPIs QD DRUG

background therapy

1500 mg IW-3718 BID + PPI; Placebo + PPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead

Study Sites (99)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Alabama Medical Group, PC

Mobile, Alabama, 36608, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Adobe Clinical Research LLC

Tucson, Arizona, 85712, United States

Location

Applied Research Center

Little Rock, Arkansas, 72212, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Anaheim Clinical Trials LLC - ERN-PPDS

Anaheim, California, 92801, United States

Location

GW Research, Inc.

Chula Vista, California, 91910, United States

Location

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Northern California Research Corp

Sacramento, California, 95821, United States

Location

Digestive Care Center

San Carlos, California, 94070, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06606, United States

Location

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States

Location

West Central Gastroenterology, LLP

Clearwater, Florida, 33756, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, 32224, United States

Location

Borland Groover Clinic

Jacksonville, Florida, 32256, United States

Location

Health Awareness Inc - MRA

Jupiter, Florida, 33458, United States

Location

Millennium Clinical Research Inc-Miami

Miami, Florida, 33125, United States

Location

Advanced Research Institute, Inc

New Port Richey, Florida, 34653, United States

Location

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

Ocoee, Florida, 34761, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Pines Clinical Research Inc

Pembroke Pines, Florida, 33028, United States

Location

DMI Research

Pinellas Park, Florida, 33782, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Atlanta Center For Gastroenterology PC

Decatur, Georgia, 30033, United States

Location

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201, United States

Location

Avicenna-DM Clinical Research

Oak Lawn, Illinois, 60453, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325, United States

Location

West Glen GI

Shawnee Mission, Kansas, 66217, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

CroNOLA, LLC.

Houma, Louisiana, 70360, United States

Location

Clinical Trials Management LLC

Mandeville, Louisiana, 70471, United States

Location

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Alan A Rosen MD PA

Baltimore, Maryland, 21215, United States

Location

Elligo Health Research

Frederick, Maryland, 21701, United States

Location

Meritus Center For Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63141, United States

Location

Kansas City Gastroenterology and Hepatology

Kansas City, Missouri, 64131, United States

Location

Advanced Research Institute - Reno

Reno, Nevada, 89511, United States

Location

AGA Clinical Research Associates, LLC. - MRA

Egg Harbor, New Jersey, 08234, United States

Location

Lovelace Scientific Resources Inc

Albuquerque, New Mexico, 87108, United States

Location

NYU School of Medicine

Great Neck, New York, 11021, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Manhattan Medical Research Practice PLLC

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Orchard Park Family Practice

Orchard Park, New York, 14127, United States

Location

Medication Management LLC

Greensboro, North Carolina, 27405, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, 27262, United States

Location

East Carolina Gastroenterology

Jacksonville, North Carolina, 28546, United States

Location

Wake Endoscopy Center

Raleigh, North Carolina, 27607, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Consultants For Clinical Research Inc

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

Legacy Research Institute

Portland, Oregon, 97232, United States

Location

Veterans Research Foundation of Pittsburgh - NAVREF

Pittsburgh, Pennsylvania, 15240, United States

Location

Consultants of Gastroenterology

Columbia, South Carolina, 29203, United States

Location

WR - ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Multi Specialty Clinical Research

Johnson City, Tennessee, 37601, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Advanced Gastroenterology-Union City

Union City, Tennessee, 38237, United States

Location

Dallas VA Medical Center - NAVREF

Dallas, Texas, 75231, United States

Location

Digestive Health Associates of Texas

Garland, Texas, 75044, United States

Location

Biopharma Informatic Inc.

Houston, Texas, 77043, United States

Location

Southwest Clinical Trials

Houston, Texas, 77074, United States

Location

Research Consultants

Houston, Texas, 77084, United States

Location

Houston Digestive Diseases Clinic

Houston, Texas, 77090, United States

Location

Pearland Physicians

Pearland, Texas, 77581, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Aspen Clinical Research LLC - MRA

Orem, Utah, 84058, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

GI Associates Gainesville

Gainesville, Virginia, 20155, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Washington Gastroenterology

Bellevue, Washington, 98004, United States

Location

Mayo Clinic Health System - Franciscan Healthcare - PPDS

La Crosse, Wisconsin, 54601, United States

Location

Wisconsin Center for Advanced Research Division of GI Associates

Milwaukee, Wisconsin, 53215, United States

Location

ALTA Clinical Research Inc

Edmonton, Alberta, T5A 4L8, Canada

Location

Taunton Surgical Centre

Oshawa, Ontario, L1H 3K4, Canada

Location

Digestive Health Clinic

Richmond Hill, Ontario, L4B 3P8, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Digestive Disease Associates Inc

Vaughan, Ontario, L4L 4Y7, Canada

Location

Recherche Clinique Sigma, Inc.

Québec, G1G 3Y8, Canada

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Ironwood Study Chair
• Organization: Ironwood Pharmaceuticals, Inc.

Info@ironwoodpharma.com

(617) 621-7722

Study Officials

• Mike Shetzline, MD, PhD

  Chief Medical Officer

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: June 20, 2018
• Primary Completion: October 7, 2020
• Study Completion: November 3, 2020
• Last Updated: August 19, 2021
• Results First Posted: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (93); CA (6)