Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:February 2014
End Date:December 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2a Study to Evaluate the Effect of IW-3718 Administered Orally for 4 Weeks in Patients With GERD Not Completely Responsive to Proton Pump Inhibitors

This study is meant to assess the effect of IW-3718 as an added treatment to ongoing
once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience
symptoms of their gastroesophageal reflux disease (GERD).


Inclusion Criteria:

- Patient is between 18 and 65 years of age at the Screening Visit; females must not be
pregnant or must not be breastfeeding;

- Patient has a confirmed diagnosis of gastroesophageal reflux disease, must be
currently taking a proton pump inhibitor (PPI), and must be experiencing GERD
symptoms as specified by the protocol.

Exclusion Criteria:

- Patient may not meet any of the excluded conditions specified in the protocol;

- Patient is experiencing alarm symptoms such as GI bleeding, anemia, vomiting,
dysphagia, or unexpected weight loss;

- Patient has a clinically significant hypersensitivity or allergies to any of the
active ingredients or excipients in the study medication.
We found this trial at
10
sites
Ironwood Investigational Site
Chattanooga, Tennessee 37421
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Chattanooga, TN
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Ironwood Investigational Site
Anaheim, California 92801
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Anaheim, CA
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Ironwood Investigational Site
Chesterfield, Michigan 48047
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Chesterfield, MI
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Ironwood Investigational Site
Cleveland, Ohio 44109
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Cleveland, OH
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Ironwood Investigational Site
Logan, Utah 84341
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Logan, UT
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Ironwood Investigational Site
Monroe, Louisiana 71201
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Monroe, LA
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Ironwood Investigational Site
Nashville, Tennessee 37212
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Nashville, TN
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Ironwood Investigational Site
North Little Rock, Arkansas 72117
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North Little Rock, AR
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Ironwood Investigational Site
Raleigh, North Carolina 27612
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Raleigh, NC
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Ironwood Investigational Site
South Ogden, Utah 84405
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South Ogden, UT
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