Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
XenoPort, Inc.
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 appro...
Eligibility Criteria
Inclusion
- confirmed diagnosis of GERD by a gastroenterologist
- minimum of 3 months of GERD symptoms prior to screening.
- currently taking an FDA approved dose of PPI therapy for symptomatic GERD for at least 4 weeks prior to screening
- experienced partial relief of GERD symptoms while receiving approved dose and regimen of PPI therapy
- experienced GERD symptoms, defined as heartburn (with or without regurgitation or other GERD symptoms) on ≥ 3 days during the week prior to screening
Exclusion
- evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal endoscopy during screening
- has not experienced any GERD symptom improvement after an adequate course of PPI treatment (at least 2 weeks)
- unstable or severe medical condition
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00978016
Start Date
September 1 2009
End Date
December 1 2010
Last Update
February 21 2021
Active Locations (64)
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1
Huntsville, Alabama, United States, 35801
2
Chandler, Arizona, United States, 85224
3
Mesa, Arizona, United States, 85203
4
Mesa, Arizona, United States, 85213