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
South Ogden, Utah 84405
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South Ogden, UT
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Ironwood Investigational Site
Anaheim, California 92801
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Anaheim, CA
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Ironwood Investigational Site
Chattanooga, Tennessee 37421
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Chattanooga, TN
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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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