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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561883
• Other study ID #: C3718-302
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

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