Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease
Lead Sponsor:
Indivior Inc.
Conditions:
GERD
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week
- 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);
- Had greater then or equal to 20 postprandial reflux episodes/2 hours recorded using impedance/pH monitoring during Screening/Baseline period (Visit 2)
Exclusion
- 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.).
- 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.)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00838396
Start Date
October 1 2005
End Date
August 1 2006
Last Update
September 14 2016
Active Locations (3)
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1
Stanford, California, United States, 94305
2
Charleston, South Carolina, United States, 29425
3
Tacoma, Washington, United States, 98403