Clinical trial NCT03561090: A 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: TERMINATED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal Reflux Disease
GERD
Proton Pump Inhibitors
IW-3718
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-19
Enrollment: 495
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: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Mobile
country: United States
facility: Alabama Medical Group, PC
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research LLC
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC - ERN-PPDS
state: California
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Sacramento
country: United States
facility: Northern California Research Corp
state: California
city: San Carlos
country: United States
facility: Digestive Care Center
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: Bristol
country: United States
facility: Connecticut Clinical Research Foundation
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Clearwater
country: United States
facility: West Central Gastroenterology, LLP
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville - PPDS
state: Florida
city: Jacksonville
country: United States
facility: Borland Groover Clinic
state: Florida
city: Jupiter
country: United States
facility: Health Awareness Inc - MRA
state: Florida
city: Miami
country: United States
facility: Millennium Clinical Research Inc-Miami
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc
state: Florida
city: Ocoee
country: United States
facility: Legacy Clinical Solutions: Sensible HealthCare, LLC - BTC - PPDS
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research Inc
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology PC
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Oak Lawn
country: United States
facility: Avicenna-DM Clinical Research
state: Illinois
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Shawnee Mission
country: United States
facility: West Glen GI
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Houma
country: United States
facility: CroNOLA, LLC.
state: Louisiana
city: Mandeville
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Alan A Rosen MD PA
state: Maryland
city: Frederick
country: United States
facility: Elligo Health Research
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center For Clinical Research
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Gastroenterology and Hepatology
state: Missouri
city: Reno
country: United States
facility: Advanced Research Institute - Reno
state: Nevada
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC. - MRA
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources Inc
state: New Mexico
city: Great Neck
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Orchard Park
country: United States
facility: Orchard Park Family Practice
state: New York
city: Greensboro
country: United States
facility: Medication Management LLC
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology
state: North Carolina
city: Raleigh
country: United States
facility: Wake Endoscopy Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Portland
country: United States
facility: Legacy Research Institute
state: Oregon
city: Pittsburgh
country: United States
facility: Veterans Research Foundation of Pittsburgh - NAVREF
state: Pennsylvania
city: Columbia
country: United States
facility: Consultants of Gastroenterology
state: South Carolina
city: Chattanooga
country: United States
facility: WR - ClinSearch, LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Johnson City
country: United States
facility: Multi Specialty Clinical Research
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology-Union City
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center - NAVREF
state: Texas
city: Garland
country: United States
facility: Digestive Health Associates of Texas
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc.
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Research Consultants
state: Texas
city: Houston
country: United States
facility: Houston Digestive Diseases Clinic
state: Texas
city: Pearland
country: United States
facility: Pearland Physicians
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Orem
country: United States
facility: Aspen Clinical Research LLC - MRA
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Gainesville
country: United States
facility: GI Associates Gainesville
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Washington Gastroenterology
state: Washington
city: La Crosse
country: United States
facility: Mayo Clinic Health System - Franciscan Healthcare - PPDS
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research Division of GI Associates
state: Wisconsin
city: Edmonton
country: Canada
facility: ALTA Clinical Research Inc
state: Alberta
city: Oshawa
country: Canada
facility: Taunton Surgical Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: Digestive Health Clinic
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc
state: Ontario
city: Québec
country: Canada
facility: Recherche Clinique Sigma, Inc.
Study officials:
affiliation: Chief Medical Officer
name: Mike Shetzline, MD, PhD
role: STUDY_CHAIR
References: