Clinical trial NCT03561883: Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal Reflux Disease
GERD
Proton Pump Inhibitor
IW-3718
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-19
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in WHSS at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period
timeFrame: Up to Week 8
measure: Proportion of Heartburn-Free Days During the 8-Week Treatment Period
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of The Southeast
state: Alabama
city: Peoria
country: United States
facility: Holland Center for Family Health
state: Arizona
city: Peoria
country: United States
facility: Hope Research Institute LLC
state: Arizona
city: Little Rock
country: United States
facility: Atria Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research
state: California
city: Murrieta
country: United States
facility: United Gastroenterologists
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories Inc
state: California
city: San Pablo
country: United States
facility: Care Access Research, San Pablo
state: California
city: Santa Ana
country: United States
facility: Paragon Rx Clinical, Inc. - Santa Ana
state: California
city: Hamden
country: United States
facility: Medical Research Center of Connecticut LLC
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Coral Gables
country: United States
facility: Optimus U Corp
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research LLC - ERN-PPDS
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Lauderdale Lakes
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group LLC - ERN-PPDS
state: Florida
city: Miami
country: United States
facility: Applemed Research Inc
state: Florida
city: Orlando
country: United States
facility: Gutierrez Medical Center
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute at Talbotton
state: Georgia
city: Decatur
country: United States
facility: Consultative Gastroenterology
state: Georgia
city: Roswell
country: United States
facility: Atlanta Center For Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - ERN-PPDS
state: Georgia
city: Gurnee
country: United States
facility: IL Gastroenterology Group
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr VA Hospital - NAVREF
state: Illinois
city: New Albany
country: United States
facility: Aquiant Research
state: Indiana
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Baton Rouge
country: United States
facility: Gastroenterology Associates LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America LA LLC
state: Louisiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies LLC
state: Massachusetts
city: Troy
country: United States
facility: Center For Digestive Health
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of West Michigan
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC
state: Michigan
city: Flowood
country: United States
facility: Gastrointestinal Associates PA
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City VA Medical Center - NAVREF
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Digestive Disease Specialists
state: Nevada
city: Las Vegas
country: United States
facility: Office of Michael Zimmerman, MD
state: Nevada
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
city: Brooklyn
country: United States
facility: NYScientific
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Johnson City
country: United States
facility: United Health Services Hospitals
state: New York
city: Syracuse
country: United States
facility: Syracuse VA Medical Center - NAVREF
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates PA
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Mount Airy
country: United States
facility: Clinical Trials of America-NC, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury LLC
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Dayton
country: United States
facility: Dayton Gastroenterology Inc
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute - ERN-PPDS
state: Oklahoma
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Research Institute
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina - ClinEdge - PPDS
state: South Carolina
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials Incorporated
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: North Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Franklin
country: United States
facility: Franklin Gastroenterology
state: Tennessee
city: Jackson
country: United States
facility: Clinical Research Solutions PC
state: Tennessee
city: Nashville
country: United States
facility: QUALITY Medical Research - Interspond - PPDS
state: Tennessee
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Carrollton
country: United States
facility: Texas Health Physicians Group
state: Texas
city: Cypress
country: United States
facility: Northside Gastroenterology
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Kelsey Research Foundation
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy and Research Center
state: Texas
city: Houston
country: United States
facility: Coastal Medical Group
state: Texas
city: San Antonio
country: United States
facility: San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
state: Texas
city: Salt Lake City
country: United States
facility: Care Access Research
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research - Gut Whisperer- ERN-PPDS
state: Utah
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Reston
country: United States
facility: The Gastroenterology Group
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners LLC
state: Virginia
city: Summit
country: United States
facility: Aurora Medical Center Summit
state: Wisconsin
city: Waukesha
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Bridgewater
country: Canada
facility: Hughie Fraser, MD
state: Nova Scotia
city: Bridgewater
country: Canada
facility: Viable Clinical Research
state: Nova Scotia
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc
state: Ontario
Study officials:
affiliation: Ironwood Pharmaceuticals, Inc.
name: Mike Shetzline, MD, PhD
role: STUDY_CHAIR
References: