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

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IW-3718
placebo
Standard-dose PPIs QD
Sponsored by
Ironwood Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal Reflux Disease, GERD, Proton Pump Inhibitor, IW-3718

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Digestive Health Specialists of The Southeast
  • Holland Center for Family Health
  • Hope Research Institute LLC
  • Atria Clinical Research
  • Preferred Research Partners
  • Hope Clinical Research, LLC
  • Om Research LLC
  • Torrance Clinical Research
  • United Gastroenterologists
  • Clinical Applications Laboratories Inc
  • Care Access Research, San Pablo
  • Paragon Rx Clinical, Inc. - Santa Ana
  • Medical Research Center of Connecticut LLC
  • Yale School of Medicine
  • Stamford Therapeutics Consortium
  • Optimus U Corp
  • Nature Coast Clinical Research LLC - ERN-PPDS
  • Jacksonville Center For Clinical Research
  • Precision Clinical Research, LLC
  • Suncoast Research Group LLC - ERN-PPDS
  • Applemed Research Inc
  • Gutierrez Medical Center
  • Columbus Regional Research Institute at Talbotton
  • Consultative Gastroenterology
  • Atlanta Center For Clinical Research
  • Clinical Research Atlanta - ERN-PPDS
  • IL Gastroenterology Group
  • Edward Hines Jr VA Hospital - NAVREF
  • Aquiant Research
  • Kansas Medical Clinic
  • Heartland Research Associates LLC
  • Gastroenterology Associates LLC
  • Texas Digestive Disease Consultants
  • Clinical Trials of America LA LLC
  • Investigative Clinical Research
  • Centennial Medical Group
  • Commonwealth Clinical Studies LLC
  • Center For Digestive Health
  • Gastroenterology Associates of West Michigan
  • Gastroenterology Associates of Western Michigan, PLC
  • Gastrointestinal Associates PA
  • Kansas City VA Medical Center - NAVREF
  • Washington University
  • Digestive Disease Specialists
  • Office of Michael Zimmerman, MD
  • Morristown Medical Center
  • Advantage Clinical Trials
  • NYScientific
  • Long Island Gastrointestinal Research Group LLP
  • United Health Services Hospitals
  • Syracuse VA Medical Center - NAVREF
  • Asheville Gastroenterology Associates PA
  • UNC Medical Center
  • Duke University Medical Center
  • Carolina Digestive Diseases
  • Clinical Trials of America-NC, LLC
  • PMG Research of Salisbury LLC
  • Trial Management Associates LLC
  • Hightop Medical Research Center
  • MetroHealth Medical Center
  • Remington Davis Inc
  • Dayton Gastroenterology Inc
  • Prestige Clinical Research
  • Central Sooner Research
  • The University of Oklahoma Health Sciences Center
  • Lynn Health Science Institute - ERN-PPDS
  • Northwest Gastroenterology Clinic
  • Research Protocol Management Specialists
  • Research Protocol Management Specialists
  • Guthrie Research Institute
  • Omega Medical Research
  • Clinical Trials of South Carolina - ClinEdge - PPDS
  • Pharmacorp Clinical Trials Incorporated
  • Gastroenterology Associates, PA
  • Coastal Carolina Research Center
  • Clinical Trials of South Carolina
  • Franklin Gastroenterology
  • Clinical Research Solutions PC
  • QUALITY Medical Research - Interspond - PPDS
  • Inquest Clinical Research
  • Texas Health Physicians Group
  • Northside Gastroenterology
  • Texas Tech University Health Sciences Center
  • Kelsey Research Foundation
  • Houston Endoscopy and Research Center
  • Coastal Medical Group
  • San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
  • Care Access Research
  • University of Utah Health Sciences Center
  • University of Utah Hospital
  • Advanced Clinical Research - Gut Whisperer- ERN-PPDS
  • Digestive and Liver Disease Specialists
  • The Gastroenterology Group
  • Clinical Research Partners LLC
  • Clinical Research Partners LLC
  • Aurora Medical Center Summit
  • Aurora Health Care
  • Hughie Fraser, MD
  • Viable Clinical Research
  • Toronto Digestive Disease Associates Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1500 mg IW-3718 BID

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
June 7, 2018
Last Updated
July 23, 2021
Sponsor
Ironwood Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03561883
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
November 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ironwood Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
Gastroesophageal Reflux Disease, GERD, Proton Pump Inhibitor, IW-3718

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1500 mg IW-3718 BID
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IW-3718
Intervention Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
Standard-dose PPIs QD
Intervention Description
background therapy
Primary Outcome Measure Information:
Title
Change From Baseline in WHSS at Week 8
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Weekly Regurgitation Frequency Score (WRFS) at Week 8
Description
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.
Time Frame
Baseline, Week 8
Title
Percentage of Participants Who Were Overall Heartburn Responders During the 8-Week Treatment Period
Description
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
Time Frame
Up to Week 8
Title
Proportion of Heartburn-Free Days During the 8-Week Treatment Period
Description
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
Time Frame
Up to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Shetzline, MD, PhD
Organizational Affiliation
Ironwood Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Digestive Health Specialists of The Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Holland Center for Family Health
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Hope Research Institute LLC
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Atria Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Hope Clinical Research, LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Torrance Clinical Research
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
United Gastroenterologists
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Clinical Applications Laboratories Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Care Access Research, San Pablo
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Paragon Rx Clinical, Inc. - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92703
Country
United States
Facility Name
Medical Research Center of Connecticut LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Optimus U Corp
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Nature Coast Clinical Research LLC - ERN-PPDS
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Jacksonville Center For Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Precision Clinical Research, LLC
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Suncoast Research Group LLC - ERN-PPDS
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Applemed Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Gutierrez Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Columbus Regional Research Institute at Talbotton
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Consultative Gastroenterology
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Atlanta Center For Clinical Research
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Clinical Research Atlanta - ERN-PPDS
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
IL Gastroenterology Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60041
Country
United States
Facility Name
Edward Hines Jr VA Hospital - NAVREF
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Aquiant Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Kansas Medical Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Heartland Research Associates LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Gastroenterology Associates LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Clinical Trials of America LA LLC
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Investigative Clinical Research
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Commonwealth Clinical Studies LLC
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Center For Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Gastroenterology Associates of West Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, PLC
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Gastrointestinal Associates PA
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Kansas City VA Medical Center - NAVREF
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Digestive Disease Specialists
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Office of Michael Zimmerman, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Advantage Clinical Trials
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
NYScientific
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Long Island Gastrointestinal Research Group LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
United Health Services Hospitals
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Syracuse VA Medical Center - NAVREF
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Asheville Gastroenterology Associates PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
UNC Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Clinical Trials of America-NC, LLC
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
PMG Research of Salisbury LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Trial Management Associates LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Remington Davis Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Dayton Gastroenterology Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute - ERN-PPDS
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Northwest Gastroenterology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Research Protocol Management Specialists
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Research Protocol Management Specialists
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Guthrie Research Institute
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Clinical Trials of South Carolina - ClinEdge - PPDS
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Pharmacorp Clinical Trials Incorporated
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Gastroenterology Associates, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Trials of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Franklin Gastroenterology
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Clinical Research Solutions PC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
QUALITY Medical Research - Interspond - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Texas Health Physicians Group
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Northside Gastroenterology
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Kelsey Research Foundation
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Houston Endoscopy and Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Coastal Medical Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Care Access Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-2101
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-2101
Country
United States
Facility Name
Advanced Clinical Research - Gut Whisperer- ERN-PPDS
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
The Gastroenterology Group
City
Reston
State/Province
Virginia
ZIP/Postal Code
22191
Country
United States
Facility Name
Clinical Research Partners LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Clinical Research Partners LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Aurora Medical Center Summit
City
Summit
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Aurora Health Care
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53186
Country
United States
Facility Name
Hughie Fraser, MD
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 3K9
Country
Canada
Facility Name
Viable Clinical Research
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 3K9
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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