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: | September 6, 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), standarddose proton pump inhibitors (PPIs).
patients with GERD who continue to have persistent symptoms, such as heartburn and
regurgitation, while receiving once-daily (QD), standarddose 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
86
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1720 2nd Ave S
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Birmingham, Alabama 35233
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Jacksonville, Florida 32216
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1709 S Rock Rd
Wichita, Kansas 67207
Wichita, Kansas 67207
316-689-6629
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415 East Yandell Drive
El Paso, Texas 79905
El Paso, Texas 79905
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33-57 Harrison Street
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Johnson City, New York 13790
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4700 North State Road 7
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940 NE 13th St
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Oklahoma City, Oklahoma 73190
(405) 271-6458
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1939 Roland Clarke Place
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