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A 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
Terminated
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 Inhibitors, 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

  • Pinnacle Research Group
  • Alabama Medical Group, PC
  • Elite Clinical Studies
  • Adobe Clinical Research LLC
  • Applied Research Center
  • Arkansas Gastroenterology
  • Anaheim Clinical Trials LLC - ERN-PPDS
  • GW Research, Inc.
  • Kindred Medical Institute for Clinical Trials, LLC
  • Facey Medical Foundation
  • Northern California Research Corp
  • Digestive Care Center
  • Precision Research Institute
  • Medical Associates Research Group, Inc.
  • Stanford University School of Medicine
  • University of Colorado Hospital
  • Gastroenterology Associates of Fairfield County
  • Connecticut Clinical Research Foundation
  • Chase Medical Research LLC
  • West Central Gastroenterology, LLP
  • Avail Clinical Research LLC
  • University of Florida
  • Mayo Clinic Jacksonville - PPDS
  • Borland Groover Clinic
  • Health Awareness Inc - MRA
  • Millennium Clinical Research Inc-Miami
  • Advanced Research Institute, Inc
  • Legacy Clinical Solutions: Sensible HealthCare, LLC - BTC - PPDS
  • Advanced Gastroenterology Associates, LLC
  • Pines Clinical Research Inc
  • DMI Research
  • Palm Beach Research Center
  • Atlanta Center For Gastroenterology PC
  • Gastroenterology Associates of Central Georgia, LLC
  • Avicenna-DM Clinical Research
  • Iowa Digestive Disease Center
  • West Glen GI
  • Cotton O'Neil Clinical Research Center
  • CroNOLA, LLC.
  • Clinical Trials Management LLC
  • Tandem Clinical Research, LLC
  • Alan A Rosen MD PA
  • Elligo Health Research
  • Meritus Center For Clinical Research
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Clinical Research Institute of Michigan
  • Minnesota Gastroenterology, P.A.
  • Clinical Research Professionals
  • Kansas City Gastroenterology and Hepatology
  • Advanced Research Institute - Reno
  • AGA Clinical Research Associates, LLC. - MRA
  • Lovelace Scientific Resources Inc
  • NYU School of Medicine
  • Beth Israel Medical Center
  • Manhattan Medical Research Practice PLLC
  • Weill Cornell Medical College
  • Orchard Park Family Practice
  • Medication Management LLC
  • Peters Medical Research, LLC
  • East Carolina Gastroenterology
  • Wake Endoscopy Center
  • Wake Research Associates, LLC
  • Consultants For Clinical Research Inc
  • Cleveland Clinic
  • Aventiv Research, Inc.
  • Great Lakes Gastroenterology Research, LLC
  • Digestive Disease Specialists, Inc.
  • Legacy Research Institute
  • Veterans Research Foundation of Pittsburgh - NAVREF
  • Consultants of Gastroenterology
  • WR - ClinSearch, LLC
  • Gastro One
  • Multi Specialty Clinical Research
  • Vanderbilt University Medical Center
  • Advanced Gastroenterology-Union City
  • Dallas VA Medical Center - NAVREF
  • Digestive Health Associates of Texas
  • Biopharma Informatic Inc.
  • Southwest Clinical Trials
  • Research Consultants
  • Houston Digestive Diseases Clinic
  • Pearland Physicians
  • Quality Research Inc
  • Texas Digestive Disease Consultants
  • Advanced Research Institute
  • Aspen Clinical Research LLC - MRA
  • New River Valley Research Institute
  • GI Associates Gainesville
  • Blue Ridge Medical Research
  • Washington Gastroenterology
  • Mayo Clinic Health System - Franciscan Healthcare - PPDS
  • Wisconsin Center for Advanced Research Division of GI Associates
  • ALTA Clinical Research Inc
  • Taunton Surgical Centre
  • Digestive Health Clinic
  • Sunnybrook Health Sciences Centre
  • Toronto Digestive Disease Associates Inc
  • Recherche Clinique Sigma, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1500 mg IW-3718 BID + PPI

Placebo + PPI

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
August 17, 2021
Sponsor
Ironwood Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03561090
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Parallel IW-3718 Phase III trial did not meet pre-specified criteria.
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
November 3, 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 Inhibitors, IW-3718

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1500 mg IW-3718 BID + PPI
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 + PPI
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
Chief Medical Officer
Official's Role
Study Chair
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Alabama Medical Group, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Adobe Clinical Research LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Applied Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Anaheim Clinical Trials LLC - ERN-PPDS
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
GW Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Northern California Research Corp
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Digestive Care Center
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Connecticut Clinical Research Foundation
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Chase Medical Research LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
West Central Gastroenterology, LLP
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Avail Clinical Research LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic Jacksonville - PPDS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Borland Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Health Awareness Inc - MRA
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Millennium Clinical Research Inc-Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Advanced Research Institute, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Legacy Clinical Solutions: Sensible HealthCare, LLC - BTC - PPDS
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Pines Clinical Research Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
DMI Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Center For Gastroenterology PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Avicenna-DM Clinical Research
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
West Glen GI
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66217
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
CroNOLA, LLC.
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Clinical Trials Management LLC
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
Tandem Clinical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Alan A Rosen MD PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Elligo Health Research
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Meritus Center For Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Kansas City Gastroenterology and Hepatology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Advanced Research Institute - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
AGA Clinical Research Associates, LLC. - MRA
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Lovelace Scientific Resources Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
NYU School of Medicine
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Manhattan Medical Research Practice PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Orchard Park Family Practice
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Medication Management LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Peters Medical Research, LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
East Carolina Gastroenterology
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Wake Endoscopy Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Consultants For Clinical Research Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Legacy Research Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Veterans Research Foundation of Pittsburgh - NAVREF
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Consultants of Gastroenterology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
WR - ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Multi Specialty Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Advanced Gastroenterology-Union City
City
Union City
State/Province
Tennessee
ZIP/Postal Code
38237
Country
United States
Facility Name
Dallas VA Medical Center - NAVREF
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Digestive Health Associates of Texas
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Biopharma Informatic Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Research Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Houston Digestive Diseases Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Pearland Physicians
City
Pearland
State/Province
Texas
ZIP/Postal Code
77581
Country
United States
Facility Name
Quality Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Aspen Clinical Research LLC - MRA
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
GI Associates Gainesville
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Washington Gastroenterology
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Mayo Clinic Health System - Franciscan Healthcare - PPDS
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Wisconsin Center for Advanced Research Division of GI Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
ALTA Clinical Research Inc
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
Taunton Surgical Centre
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 3K4
Country
Canada
Facility Name
Digestive Health Clinic
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 3P8
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Recherche Clinique Sigma, Inc.
City
Québec
ZIP/Postal Code
G1G 3Y8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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