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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03561883
Other study ID # C3718-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 6, 2018
Est. completion date November 6, 2020

Study information

Verified date July 2021
Source Ironwood Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 609
Est. completion date November 6, 2020
Est. primary completion date July 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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. Exclusion Criteria: 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. NOTE: Other inclusion and exclusion criteria apply, per the study protocol.

Study Design


Intervention

Drug:
IW-3718
oral tablet
placebo
oral tablet
Standard-dose PPIs QD
background therapy

Locations

Country Name City State
Canada Hughie Fraser, MD Bridgewater Nova Scotia
Canada Viable Clinical Research Bridgewater Nova Scotia
Canada Toronto Digestive Disease Associates Inc Vaughan Ontario
United States Investigative Clinical Research Annapolis Maryland
United States Asheville Gastroenterology Associates PA Asheville North Carolina
United States Gastroenterology Associates LLC Baton Rouge Louisiana
United States Texas Digestive Disease Consultants Baton Rouge Louisiana
United States Inquest Clinical Research Baytown Texas
United States University of Alabama at Birmingham Birmingham Alabama
United States Commonwealth Clinical Studies LLC Brockton Massachusetts
United States Advantage Clinical Trials Bronx New York
United States NYScientific Brooklyn New York
United States Hope Clinical Research, LLC Canoga Park California
United States Texas Health Physicians Group Carrollton Texas
United States UNC Medical Center Chapel Hill North Carolina
United States Clinical Trials of South Carolina - ClinEdge - PPDS Charleston South Carolina
United States Pharmacorp Clinical Trials Incorporated Charleston South Carolina
United States Hightop Medical Research Center Cincinnati Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Columbus Regional Research Institute at Talbotton Columbus Georgia
United States Remington Davis Inc Columbus Ohio
United States Optimus U Corp Coral Gables Florida
United States Northside Gastroenterology Cypress Texas
United States Dayton Gastroenterology Inc Dayton Ohio
United States Consultative Gastroenterology Decatur Georgia
United States Digestive Health Specialists of The Southeast Dothan Alabama
United States Duke University Medical Center Durham North Carolina
United States Texas Tech University Health Sciences Center El Paso Texas
United States Centennial Medical Group Elkridge Maryland
United States Gastrointestinal Associates PA Flowood Mississippi
United States Franklin Gastroenterology Franklin Tennessee
United States Prestige Clinical Research Franklin Ohio
United States Long Island Gastrointestinal Research Group LLP Great Neck New York
United States Carolina Digestive Diseases Greenville North Carolina
United States Gastroenterology Associates, PA Greenville South Carolina
United States IL Gastroenterology Group Gurnee Illinois
United States Medical Research Center of Connecticut LLC Hamden Connecticut
United States Edward Hines Jr VA Hospital - NAVREF Hines Illinois
United States Coastal Medical Group Houston Texas
United States Houston Endoscopy and Research Center Houston Texas
United States Kelsey Research Foundation Houston Texas
United States Nature Coast Clinical Research LLC - ERN-PPDS Inverness Florida
United States Clinical Research Solutions PC Jackson Tennessee
United States Jacksonville Center For Clinical Research Jacksonville Florida
United States United Health Services Hospitals Johnson City New York
United States Kansas City VA Medical Center - NAVREF Kansas City Missouri
United States Om Research LLC Lancaster California
United States Digestive Disease Specialists Las Vegas Nevada
United States Office of Michael Zimmerman, MD Las Vegas Nevada
United States Precision Clinical Research, LLC Lauderdale Lakes Florida
United States Atria Clinical Research Little Rock Arkansas
United States Preferred Research Partners Little Rock Arkansas
United States Torrance Clinical Research Lomita California
United States Applemed Research Inc Miami Florida
United States Suncoast Research Group LLC - ERN-PPDS Miami Florida
United States Morristown Medical Center Morristown New Jersey
United States Clinical Trials of America-NC, LLC Mount Airy North Carolina
United States Coastal Carolina Research Center Mount Pleasant South Carolina
United States United Gastroenterologists Murrieta California
United States QUALITY Medical Research - Interspond - PPDS Nashville Tennessee
United States Aquiant Research New Albany Indiana
United States Yale School of Medicine New Haven Connecticut
United States Digestive and Liver Disease Specialists Norfolk Virginia
United States Central Sooner Research Norman Oklahoma
United States Clinical Trials of South Carolina North Charleston South Carolina
United States Lynn Health Science Institute - ERN-PPDS Oklahoma City Oklahoma
United States The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Gutierrez Medical Center Orlando Florida
United States Holland Center for Family Health Peoria Arizona
United States Hope Research Institute LLC Peoria Arizona
United States Research Protocol Management Specialists Pittsburgh Pennsylvania
United States Research Protocol Management Specialists Pittsburgh Pennsylvania
United States Northwest Gastroenterology Clinic Portland Oregon
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 Atlanta Center For Clinical Research Roswell Georgia
United States Washington University Saint Louis Missouri
United States PMG Research of Salisbury LLC Salisbury North Carolina
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 San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC) San Antonio Texas
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 Guthrie Research Institute Sayre Pennsylvania
United States Stamford Therapeutics Consortium Stamford Connecticut
United States Clinical Research Atlanta - ERN-PPDS Stockbridge Georgia
United States Aurora Medical Center Summit Summit Wisconsin
United States Syracuse VA Medical Center - NAVREF Syracuse New York
United States Kansas Medical Clinic Topeka Kansas
United States Center For Digestive Health Troy Michigan
United States Omega Medical Research Warwick Rhode Island
United States Aurora Health Care Waukesha Wisconsin
United States Advanced Clinical Research - Gut Whisperer- ERN-PPDS West Jordan Utah
United States Clinical Trials of America LA LLC West Monroe Louisiana
United States Heartland Research Associates LLC Wichita Kansas
United States Trial Management Associates LLC Wilmington North Carolina
United States Gastroenterology Associates of West Michigan Wyoming Michigan
United States Gastroenterology Associates of Western Michigan, PLC Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
Ironwood Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 The WRFS is defined as the average of available daily regurgitation frequency scores (DRFS) during a week. DRFS is defined as the maximum score of the 2 items measuring regurgitation from a particular day (Item #6 "Regurgitation [liquid or food moving upwards toward your throat or mouth]" and Item #7 "An acid or bitter taste in the mouth"). The DRFS items are assessed on a 4-point ordinal scale, where 0=Never, 1=Rarely, 2-Sometimes, 3=Often, and 4=Very Often; higher scores indicate worse symptoms. A negative change from baseline indicates improvement. Baseline, Week 8
Secondary Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of >/= 45% from baseline in WHSS. A participant who reported heartburn severity for less than 4 days during a week is not considered a responder for that week.
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
Up to Week 8
Secondary Proportion of Heartburn-Free Days During the 8-Week Treatment Period Proportion of heartburn-free days is calculated as the number of heartburn-free (DHSS=0) days divided by the number of diary entry days. 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 Up to Week 8
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