A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease



Status:Completed
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:October 2005
End Date:August 2006

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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover, Single Dose-Finding Study to Assess the Efficacy and Safety of Controlled Release XP19986 in Patients With Gastroesophageal Reflux Disease

The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil
(XP19986) compared to placebo in patients with gastroesophageal reflux disease.


Inclusion Criteria:

1. History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week

2. Discontinuation of drugs used to treat GERD (PPIs, H2-blockers) and/or drugs known to
cause GERD symptoms (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs]) for 7 days
prior to baseline (Visit 2);

3. Had greater then or equal to 20 postprandial reflux episodes/2 hours recorded using
impedance/pH monitoring during Screening/Baseline period (Visit 2)

Exclusion Criteria:

1. History of gastrointestinal disorders other than GERD that may have significantly
affected the assessment of reflux episodes or GERD symptoms (e.g. Barrett's
Esophagus, active gastric or duodenal ulcer disease, achalasia, scleroderma, etc.).

2. Medical conditions that could have affected assessments of reflux episodes or GERD
symptoms (e.g. history of nausea and/or vomiting, neurologic/psychiatric disorders,
cardiac disease [e.g. angina], lung disease [e.g. asthma, cough], etc.)
We found this trial at
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Tacoma, WA
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Charleston, South Carolina 29412
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Charleston, SC
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Stanford, CA
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