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 |
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).
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
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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860 Peachwood Drive
DeLand, Florida 32720
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...
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330 Brookline Ave
Boston, Massachusetts 02215
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...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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610 3rd St # 206
Macon, Georgia 31201
Macon, Georgia 31201
Phone: 478-464-2600
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1211 Medical Center Dr
Nashville, Tennessee 37232
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...
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291 Campus Dr
Stanford, California 94305
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...
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823 SW Mulvane St
Topeka, Kansas 66606
Topeka, Kansas 66606
785-368-0741
Phone: 785-270-4856
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
West Palm Beach, Florida 33409
561-689-0606
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Brookfield, Wisconsin 53005
Phone: 414-908-6630
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Egg Harbor Township, New Jersey 08234
Phone: 609-407-1220
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4500 San Pablo Road South
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Phone: 904-953-2254
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La Crosse, Wisconsin 54601
Phone: 608-392-6880
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2160 South 1st Avenue
Maywood, Illinois 60153
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...
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Phone: 405-702-1300
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Pittsburgh, Pennsylvania 15240
Phone: 412-360-3788
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
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...
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1109 East Reelfoot Avenue
Union City, Tennessee 38261
Union City, Tennessee 38261
Phone: 731-884-0600
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