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A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) - NCT00978016-15243(Clinical Trial 331208)



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City:  Pittsburgh
State:  
PA
Zip Code: 15243
Conditions: Gastroesophageal Reflux Disease
Purpose: 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).
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: September 22, 2010
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