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

NCT03561883 | Completed Phase 3 Results FDA Drug

• 1 other identifier: C3718-302
• Study Type: interventional
• Target: 609
• Locations: 2 countries
• Sites: 101

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 Inhibitor; 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

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

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

placebo DRUG

oral tablet

Placebo

Standard-dose PPIs QD DRUG

background therapy

1500 mg IW-3718 BID; Placebo

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 (101)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Digestive Health Specialists of The Southeast

Dothan, Alabama, 36305, United States

Location

Holland Center for Family Health

Peoria, Arizona, 85381, United States

Location

Hope Research Institute LLC

Peoria, Arizona, 85381, United States

Location

Atria Clinical Research

Little Rock, Arkansas, 72209, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Hope Clinical Research, LLC

Canoga Park, California, 91303, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

Torrance Clinical Research

Lomita, California, 90717, United States

Location

United Gastroenterologists

Murrieta, California, 92563, United States

Location

Clinical Applications Laboratories Inc

San Diego, California, 92103, United States

Location

Care Access Research, San Pablo

San Pablo, California, 94806, United States

Location

Paragon Rx Clinical, Inc. - Santa Ana

Santa Ana, California, 92703, United States

Location

Medical Research Center of Connecticut LLC

Hamden, Connecticut, 06518, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Optimus U Corp

Coral Gables, Florida, 33134, United States

Location

Nature Coast Clinical Research LLC - ERN-PPDS

Inverness, Florida, 34452, United States

Location

Jacksonville Center For Clinical Research

Jacksonville, Florida, 32207, United States

Location

Precision Clinical Research, LLC

Lauderdale Lakes, Florida, 33319, United States

Location

Suncoast Research Group LLC - ERN-PPDS

Miami, Florida, 33135, United States

Location

Applemed Research Inc

Miami, Florida, 33155, United States

Location

Gutierrez Medical Center

Orlando, Florida, 32807, United States

Location

Columbus Regional Research Institute at Talbotton

Columbus, Georgia, 31904, United States

Location

Consultative Gastroenterology

Decatur, Georgia, 30034, United States

Location

Atlanta Center For Clinical Research

Roswell, Georgia, 30075, United States

Location

Clinical Research Atlanta - ERN-PPDS

Stockbridge, Georgia, 30281, United States

Location

IL Gastroenterology Group

Gurnee, Illinois, 60041, United States

Location

Edward Hines Jr VA Hospital - NAVREF

Hines, Illinois, 60141, United States

Location

Aquiant Research

New Albany, Indiana, 47150, United States

Location

Kansas Medical Clinic

Topeka, Kansas, 66606, United States

Location

Heartland Research Associates LLC

Wichita, Kansas, 67207, United States

Location

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809, United States

Location

Texas Digestive Disease Consultants

Baton Rouge, Louisiana, 70809, United States

Location

Clinical Trials of America LA LLC

West Monroe, Louisiana, 71291, United States

Location

Investigative Clinical Research

Annapolis, Maryland, 21401, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Commonwealth Clinical Studies LLC

Brockton, Massachusetts, 02302, United States

Location

Center For Digestive Health

Troy, Michigan, 48098, United States

Location

Gastroenterology Associates of West Michigan

Wyoming, Michigan, 49519, United States

Location

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, 49519, United States

Location

Gastrointestinal Associates PA

Flowood, Mississippi, 39232, United States

Location

Kansas City VA Medical Center - NAVREF

Kansas City, Missouri, 64128, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Digestive Disease Specialists

Las Vegas, Nevada, 89128, United States

Location

Office of Michael Zimmerman, MD

Las Vegas, Nevada, 89128, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

NYScientific

Brooklyn, New York, 11235, United States

Location

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023, United States

Location

United Health Services Hospitals

Johnson City, New York, 13790, United States

Location

Syracuse VA Medical Center - NAVREF

Syracuse, New York, 13210, United States

Location

Advantage Clinical Trials

The Bronx, New York, 10468, United States

Location

Asheville Gastroenterology Associates PA

Asheville, North Carolina, 28801, United States

Location

UNC Medical Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolina Digestive Diseases

Greenville, North Carolina, 27834, United States

Location

Clinical Trials of America-NC, LLC

Mount Airy, North Carolina, 27030, United States

Location

PMG Research of Salisbury LLC

Salisbury, North Carolina, 28144, United States

Location

Trial Management Associates LLC

Wilmington, North Carolina, 28403, United States

Location

Hightop Medical Research Center

Cincinnati, Ohio, 45224, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Remington Davis Inc

Columbus, Ohio, 43214, United States

Location

Dayton Gastroenterology Inc

Dayton, Ohio, 45440, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Lynn Health Science Institute - ERN-PPDS

Oklahoma City, Oklahoma, 73112, United States

Location

Northwest Gastroenterology Clinic

Portland, Oregon, 97210, United States

Location

Research Protocol Management Specialists

Pittsburgh, Pennsylvania, 15241, United States

Location

Research Protocol Management Specialists

Pittsburgh, Pennsylvania, 15243, United States

Location

Guthrie Research Institute

Sayre, Pennsylvania, 18840, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Clinical Trials of South Carolina - ClinEdge - PPDS

Charleston, South Carolina, 29406, United States

Location

Pharmacorp Clinical Trials Incorporated

Charleston, South Carolina, 29412, United States

Location

Gastroenterology Associates, PA

Greenville, South Carolina, 29615, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Trials of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Franklin Gastroenterology

Franklin, Tennessee, 37067, United States

Location

Clinical Research Solutions PC

Jackson, Tennessee, 38305, United States

Location

QUALITY Medical Research - Interspond - PPDS

Nashville, Tennessee, 37211, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

Texas Health Physicians Group

Carrollton, Texas, 75007, United States

Location

Northside Gastroenterology

Cypress, Texas, 77429, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Kelsey Research Foundation

Houston, Texas, 77025, United States

Location

Houston Endoscopy and Research Center

Houston, Texas, 77079, United States

Location

Coastal Medical Group

Houston, Texas, 77089, United States

Location

San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)

San Antonio, Texas, 78229, United States

Location

Care Access Research

Salt Lake City, Utah, 84124, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132-2101, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132-2101, United States

Location

Advanced Clinical Research - Gut Whisperer- ERN-PPDS

West Jordan, Utah, 84088, United States

Location

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

The Gastroenterology Group

Reston, Virginia, 22191, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23220, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23235, United States

Location

Aurora Medical Center Summit

Summit, Wisconsin, 53066, United States

Location

Aurora Health Care

Waukesha, Wisconsin, 53186, United States

Location

Hughie Fraser, MD

Bridgewater, Nova Scotia, B4V 3K9, Canada

Location

Viable Clinical Research

Bridgewater, Nova Scotia, B4V 3K9, Canada

Location

Toronto Digestive Disease Associates Inc

Vaughan, Ontario, L4L 4Y7, 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

  Ironwood Pharmaceuticals, Inc.

  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: September 6, 2018
• Primary Completion: July 28, 2020
• Study Completion: November 6, 2020
• Last Updated: August 18, 2021
• Results First Posted: August 18, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (98)