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
Verified date | July 2021 |
Source | Ironwood Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Ironwood Pharmaceuticals, Inc. |
United States, Canada,
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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