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
sites
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-934-4154
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Phone: 904-732-6683
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1709 S Rock Rd
Wichita, Kansas 67207
Wichita, Kansas 67207
316-689-6629
Phone: 316-689-6645
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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415 East Yandell Drive
El Paso, Texas 79905
El Paso, Texas 79905
Phone: 915-215-5205
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33-57 Harrison Street
Johnson City, New York 13790
Johnson City, New York 13790
Phone: 607-798-7345
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
Lauderdale Lakes, Florida 33319
Phone: 954-915-9991
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Phone: 405-271-5428
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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1939 Roland Clarke Place
Reston, Virginia 20191
Reston, Virginia 20191
Phone: 703-766-2650
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150 East Sonterra Boulevard
San Antonio, Texas 78229
San Antonio, Texas 78229
Phone: 210-558-2794
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