Status:
COMPLETED
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Shire
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 GE...
Eligibility Criteria
Inclusion
- Written Informed Consent Form signed voluntarily before the first study-related activity.
- Aged between 18 and 70 years, inclusive.
- Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
- Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
- Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
- Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
- 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
- Subjects who show no response to heartburn while on PPI therapy.
- Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
- Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
- Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.
- Alarm symptoms suggestive of malignancies or organic disease.
Key Trial Info
Start Date :
February 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2013
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT01472939
Start Date
February 27 2012
End Date
May 14 2013
Last Update
June 9 2021
Active Locations (88)
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Little Rock, Arkansas, United States, 72205
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