Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:3/30/2013
Start Date:March 2012
End Date:May 2013
Contact:Shire Call Center
Phone:001 866-842-5335

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A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) With Persistent Regurgitation With or Without Heartburn


The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor
agonist compared to placebo on residual symptoms (regurgitation with or without heartburn)
in subjects with GERD who have persistent symptoms while on PPI therapy.


Inclusion Criteria:

1. Written Informed Consent Form signed voluntarily before the first study-related
activity.

2. Aged between 18 and 70 years, inclusive.

3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and
regurgitation) prior to PPI therapy.

4. Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.

5. Subjects who have persistent symptoms of regurgitation for 3 or more days over the
past week with or without heartburn while on PPI.

6. Subjects have at least some improvement to the symptom of heartburn while on PPI
therapy.

7. Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which
the last 4 weeks are on a stable labeled dose for any GERD indication according to
the country label, where a change of PPI therapy would not impact the symptoms
(twice-daily dosing of PPI is not allowed in the last 4 weeks)

Exclusion Criteria:

1. Subjects who show no response to heartburn while on PPI therapy.

2. Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms
(heartburn and/or regurgitation).

3. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects
with major GI disorders.

4. Presence of severe and clinically uncontrolled cardiovascular, liver, lung or
neurologic disease, cancer or AIDS.

5. Alarm symptoms suggestive of malignancies or organic disease.
We found this trial at
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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2023 Carmel Road
1, Charlotte, North Carolina 28226
704-366-3001
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875 Military Trl # 210
Jupiter, Florida 33458
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3100 Duraleigh Road
Meredith, North Carolina 27612
919-781-2514
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Rockford, Illinois 61107
815-397-7340
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4751 66th St N
St Petersburg, Florida 33709
727-347-8839
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Tucson, Arizona 85741
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Warwick, Rhode Island 02886
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