Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- Registration Number
- NCT03561883
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 609
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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Standard-dose PPIs QD 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. 1500 mg IW-3718 BID IW-3718 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. 1500 mg IW-3718 BID Standard-dose PPIs QD 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. Placebo placebo 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in WHSS at Week 8 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Proportion of Heartburn-Free Days During the 8-Week Treatment Period Up to Week 8 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
Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8 Baseline, 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.
Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period Up to Week 8 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
Trial Locations
- Locations (99)
Long Island Gastrointestinal Research Group LLP
🇺🇸Great Neck, New York, United States
Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Precision Clinical Research, LLC
🇺🇸Lauderdale Lakes, Florida, United States
Clinical Research Atlanta - ERN-PPDS
🇺🇸Stockbridge, Georgia, United States
Digestive Health Specialists of The Southeast
🇺🇸Dothan, Alabama, United States
Hope Clinical Research, LLC
🇺🇸Canoga Park, California, United States
Nature Coast Clinical Research LLC - ERN-PPDS
🇺🇸Inverness, Florida, United States
Guthrie Research Institute
🇺🇸Sayre, Pennsylvania, United States
Advantage Clinical Trials
🇺🇸Bronx, New York, United States
Gastroenterology Associates, PA
🇺🇸Greenville, South Carolina, United States
Hope Research Institute LLC
🇺🇸Peoria, Arizona, United States
Clinical Research Solutions PC
🇺🇸Jackson, Tennessee, United States
Om Research LLC
🇺🇸Lancaster, California, United States
Asheville Gastroenterology Associates PA
🇺🇸Asheville, North Carolina, United States
Texas Digestive Disease Consultants
🇺🇸Baton Rouge, Louisiana, United States
Edward Hines Jr VA Hospital - NAVREF
🇺🇸Hines, Illinois, United States
Atria Clinical Research
🇺🇸Little Rock, Arkansas, United States
Holland Center for Family Health
🇺🇸Peoria, Arizona, United States
Torrance Clinical Research
🇺🇸Lomita, California, United States
Syracuse VA Medical Center - NAVREF
🇺🇸Syracuse, New York, United States
United Gastroenterologists
🇺🇸Murrieta, California, United States
Clinical Trials of America LA LLC
🇺🇸West Monroe, Louisiana, United States
Consultative Gastroenterology
🇺🇸Decatur, Georgia, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Jacksonville Center For Clinical Research
🇺🇸Jacksonville, Florida, United States
Aquiant Research
🇺🇸New Albany, Indiana, United States
United Health Services Hospitals
🇺🇸Johnson City, New York, United States
Franklin Gastroenterology
🇺🇸Franklin, Tennessee, United States
IL Gastroenterology Group
🇺🇸Gurnee, Illinois, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Gastrointestinal Associates PA
🇺🇸Flowood, Mississippi, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
Gastroenterology Associates LLC
🇺🇸Baton Rouge, Louisiana, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
NYScientific
🇺🇸Brooklyn, New York, United States
Trial Management Associates LLC
🇺🇸Wilmington, North Carolina, United States
The Gastroenterology Group
🇺🇸Reston, Virginia, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Aurora Health Care
🇺🇸Waukesha, Wisconsin, United States
Aurora Medical Center Summit
🇺🇸Summit, Wisconsin, United States
Northside Gastroenterology
🇺🇸Cypress, Texas, United States
Texas Health Physicians Group
🇺🇸Carrollton, Texas, United States
Hughie Fraser, MD
🇨🇦Bridgewater, Nova Scotia, Canada
Heartland Research Associates LLC
🇺🇸Wichita, Kansas, United States
Kansas Medical Clinic
🇺🇸Topeka, Kansas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Clinical Applications Laboratories Inc
🇺🇸San Diego, California, United States
Suncoast Research Group LLC - ERN-PPDS
🇺🇸Miami, Florida, United States
Office of Michael Zimmerman, MD
🇺🇸Las Vegas, Nevada, United States
Applemed Research Inc
🇺🇸Miami, Florida, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute - ERN-PPDS
🇺🇸Oklahoma City, Oklahoma, United States
QUALITY Medical Research - Interspond - PPDS
🇺🇸Nashville, Tennessee, United States
Kelsey Research Foundation
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Northwest Gastroenterology Clinic
🇺🇸Portland, Oregon, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Research Protocol Management Specialists
🇺🇸Pittsburgh, Pennsylvania, United States
Houston Endoscopy and Research Center
🇺🇸Houston, Texas, United States
Coastal Medical Group
🇺🇸Houston, Texas, United States
San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
🇺🇸San Antonio, Texas, 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
Paragon Rx Clinical, Inc. - Santa Ana
🇺🇸Santa Ana, California, United States
Care Access Research, San Pablo
🇺🇸San Pablo, California, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Optimus U Corp
🇺🇸Coral Gables, Florida, United States
Atlanta Center For Clinical Research
🇺🇸Roswell, Georgia, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Commonwealth Clinical Studies LLC
🇺🇸Brockton, Massachusetts, United States
Center For Digestive Health
🇺🇸Troy, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC
🇺🇸Wyoming, Michigan, United States
Digestive Disease Specialists
🇺🇸Las Vegas, Nevada, United States
Clinical Trials of America-NC, LLC
🇺🇸Mount Airy, North Carolina, United States
Dayton Gastroenterology Inc
🇺🇸Dayton, Ohio, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Clinical Trials of South Carolina
🇺🇸North Charleston, South Carolina, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Clinical Research Partners LLC
🇺🇸Richmond, Virginia, United States
Viable Clinical Research
🇨🇦Bridgewater, Nova Scotia, Canada
Advanced Clinical Research - Gut Whisperer- ERN-PPDS
🇺🇸West Jordan, Utah, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
PMG Research of Salisbury LLC
🇺🇸Salisbury, North Carolina, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Gutierrez Medical Center
🇺🇸Orlando, Florida, United States
Kansas City VA Medical Center - NAVREF
🇺🇸Kansas City, Missouri, 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
Medical Research Center of Connecticut LLC
🇺🇸Hamden, Connecticut, United States
Columbus Regional Research Institute at Talbotton
🇺🇸Columbus, Georgia, United States
Toronto Digestive Disease Associates Inc
🇨🇦Vaughan, Ontario, Canada
Gastroenterology Associates of West Michigan
🇺🇸Wyoming, Michigan, United States