A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) - NCT00978016-18964 (Clinical Trial 331209)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy331209.aspx
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| City: |
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Souderton |
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State:
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PA |
| Zip Code: |
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18964 |
| Conditions: |
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Gastroesophageal Reflux Disease |
| Purpose: |
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The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil
(XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms
despite therapy with approved doses of a Proton Pump Inhibitor (PPI).
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. confirmed diagnosis of GERD by a gastroenterologist
2. minimum of 3 months of GERD symptoms prior to screening.
3. currently taking an FDA approved dose of PPI therapy for symptomatic GERD for at
least 4 weeks prior to screening
4. experienced partial relief of GERD symptoms while receiving approved dose and regimen
of PPI therapy
5. experienced GERD symptoms, defined as heartburn (with or without regurgitation or
other GERD symptoms) on ≥ 3 days during the week prior to screening
Exclusion Criteria:
1. evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal
endoscopy during screening
2. has not experienced any GERD symptom improvement after an adequate course of PPI
treatment (at least 2 weeks)
3. unstable or severe medical condition |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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