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



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:June 20, 2018
End Date:January 2020
Contact:Ironwood Study Team
Email:IW3718@ironwoodpharma.com

Use our guide to learn which trials are right for you!

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

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 proton pump inhibitors (PPIs).


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 proton pump inhibitor (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, 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.
We found this trial at
85
sites
1101 Medical Center Boulevard
Marrero, Louisiana 70072
Phone: 407-304-0044
?
mi
from
Marrero, LA
Click here to add this to my saved trials
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Phone: 386-740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-2138
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-6523
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
Phone: 732-972-6996
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
4800 Belfort Rd # 2
Jacksonville, Florida 32256
Phone: 904-386-7205
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
610 3rd St # 206
Macon, Georgia 31201
Phone: 478-464-2600
?
mi
from
Macon, GA
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-4643
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
Phone: 954-435-9990
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Phone: 650-736-0431
Stanford University School of Medicine Vast in both its physical scale and its impact on...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
Phone: 785-270-4856
?
mi
from
Topeka, KS
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
Phone: 505-348-9500
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Anaheim, California 92801
Phone: 714-774-7777
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anniston, Alabama 36207
Phone: 256-236-0055
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Aurora, California 80045
Phone: 708-216-0464
?
mi
from
Aurora, CA
Click here to add this to my saved trials
Baltimore, Maryland 21215
Phone: 410-601-8255
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellevue, Washington 98004
Phone: 425-452-8547
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
Phone: 203-333-3328
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Bristol, Connecticut 06010
Phone: 860-585-3838
?
mi
from
Bristol, CT
Click here to add this to my saved trials
Brookfield, Wisconsin 53005
Phone: 414-908-6630
?
mi
from
Brookfield, WI
Click here to add this to my saved trials
6035 Shallowford Road
Chattanooga, Tennessee 37421
Phone: 423-698-4584
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Michigan 48098
Phone: 586-598-3329
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chesterfield, Missouri 63141
Phone: 636-220-1200
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Christiansburg, Virginia 24073
Phone: 540-381-3086
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Chula Vista, California 91910
Phone: 619-585-8882
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Phone: 513-872-4549
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
Phone: 727-347-0536
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clive, Iowa 50325
Phone: 515-225-6050
?
mi
from
Clive, IA
Click here to add this to my saved trials
Columbus, Ohio 43213
Phone: 614-501-6164
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Corona, California 92879
Phone: 951-220-4029
?
mi
from
Corona, CA
Click here to add this to my saved trials
Dallas, Texas 75231
Phone: 214-857-1603
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30033
Phone: 404-296-1986
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Edmonton, Alberta
Phone: (780) 473-6728
?
mi
from
Edmonton,
Click here to add this to my saved trials
Egg Harbor Township, New Jersey 08234
Phone: 609-407-1220
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
Evanston, Illinois
Phone: 847-570-2615
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Germantown, Tennessee 38138
Phone: 901-820-0090
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Great Neck, New York 11021
Phone: 516-466-2340
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greensboro, North Carolina 27408
Phone: 336-214-6562
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Phone: 301-733-4404
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
HIgh Point, North Carolina 27262
Phone: 336-883-9773
?
mi
from
HIgh Point, NC
Click here to add this to my saved trials
Houma, Louisiana 70360
Phone: 985-601-2662
?
mi
from
Houma, LA
Click here to add this to my saved trials
Houston, Texas 77074
Phone: 713-777-3000
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77084
Phone: 281-944-4368
?
mi
from
Houston, TX
Click here to add this to my saved trials
17070 Red Oak Drive
Houston, Texas 77090
Phone: 281-444-2399
?
mi
from
Houston, TX
Click here to add this to my saved trials
19255 Park Row Drive
Houston, Texas 77084
Phone: 281-944-3610
?
mi
from
Houston, TX
Click here to add this to my saved trials
4500 San Pablo Road South
Jacksonville, Florida 32224
Phone: 904-953-2254
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville, North Carolina 28546
Phone: 910-353-6158
?
mi
from
Jacksonville, NC
Click here to add this to my saved trials
Johnson City, Tennessee 37601
Phone: 423-854-8952
?
mi
from
Johnson City, TN
Click here to add this to my saved trials
Jupiter, Florida 33458
Phone: 561-741-2033
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
Kansas City, Missouri 64131
Phone: 816-759-5274
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kew Gardens, New York 11415
Phone: 866-879-2507
?
mi
from
Kew Gardens, NY
Click here to add this to my saved trials
La Crosse, Wisconsin 54601
Phone: 608-392-6880
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
Little Rock, Arkansas 72212
Phone: 501-954-7822
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Lynchburg, Virginia 24502
Phone: 434-455-8670
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Mandeville, Louisiana 70471
Phone: 504-455-1310
?
mi
from
Mandeville, LA
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Phone: 615-885-1093
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Mentor, Ohio 44060
Phone: 440-205-1225
?
mi
from
Mentor, OH
Click here to add this to my saved trials
Mission Hills, California 91345
Phone: 818-837-7067
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
6001 Airport Boulevard
Mobile, Alabama 36608
Phone: 251-459-8023
?
mi
from
Mobile, AL
Click here to add this to my saved trials
New Port Richey, Florida
Phone: 727-835-3261
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
New York, New York 10016
Phone: 212-480-3333
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10021
Phone: 416-586-5121
?
mi
from
New York, NY
Click here to add this to my saved trials
North Little Rock, Arkansas
Phone: 501-945-9300
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Ogden, Utah 84405
Phone: 801-409-2040
?
mi
from
Ogden, UT
Click here to add this to my saved trials
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
Phone: 405-702-1300
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orem, Utah 84058
Phone: 801-356-5555
?
mi
from
Orem, UT
Click here to add this to my saved trials
Palm Harbor, Florida 34684
Phone: 727-216-0768
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Pearland, Texas 77581
Phone: 281-485-0334
?
mi
from
Pearland, TX
Click here to add this to my saved trials
Phoenix, Arizona 85018
Phone: 602-788-3437
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15240
Phone: 412-360-3788
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plymouth, Minnesota 55446
Phone: 612-870-5560
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
Portland, Oregon 97232
Phone: 888-888-8888
?
mi
from
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina 27607
Phone: 919-783-4888
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Reno, Nevada 89511
Phone: 801-553-9567
?
mi
from
Reno, NV
Click here to add this to my saved trials
3840 Watt Avenue
Sacramento, California 95821
Phone: 916-484-0500
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas 78209
Phone: 210-824-5678
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Carlos, California 94070
Phone: 650-596-8800
?
mi
from
San Carlos, CA
Click here to add this to my saved trials
San Diego, California 92123
Phone: 858-277-5678
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Southlake, Texas 76092
Phone: 817-424-1525
?
mi
from
Southlake, TX
Click here to add this to my saved trials
Tomball, Texas 77375
Phone: 281-517-0550
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Tucson, Arizona 85712
Phone: 520-318-1236
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
1109 East Reelfoot Avenue
Union City, Tennessee 38261
Phone: 731-884-0600
?
mi
from
Union City, TN
Click here to add this to my saved trials