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



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:September 2009
End Date:December 2010

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A Dose-Response Efficacy and Safety Study of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) Who Are Incomplete Responders to a Proton Pump Inhibitor (PPI)

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).


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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