A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
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)
1 other identifier
interventional
460
2 countries
64
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 approved doses of a Proton Pump Inhibitor (PPI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Shorter than P25 for phase_2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 21, 2021
February 1, 2021
1.2 years
September 11, 2009
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heartburn Episodes
number of episodes
6 weeks
Secondary Outcomes (1)
Regurgitation Episodes
6 weeks
Study Arms (5)
arbaclofen placarbil-Cohort 1
EXPERIMENTALarbaclofen placarbil 20 mg QD with PPI\* \* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
arbaclofen placarbil-Cohort 2
EXPERIMENTALarbaclofen placarbil 40 mg QD with PPI\* \* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
arbaclofen placarbil-Cohort 3
EXPERIMENTALarbaclofen placarbil 20 mg BID with PPI\* \* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
arbaclofen placarbil-Cohort 4
EXPERIMENTALarbaclofen placarbil 30 mg BID with PPI\* \* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
Placebo-Cohort 5
PLACEBO COMPARATORPlacebo dose with PPI\* \* Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
Interventions
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg QD) for 7 weeks including titration and taper periods
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 40 mg QD) with for 7 weeks including titration and taper periods
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg BID) for 7 weeks including titration and taper periods
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 30 mg BID) for 7 weeks including titration and taper periods
Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XenoPort, Inc.lead
Study Sites (64)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Chandler, Arizona, 85224, United States
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Mesa, Arizona, 85203, United States
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Mesa, Arizona, 85213, United States
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Scottsdale, Arizona, 85251, United States
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Tucson, Arizona, 85715, United States
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Sherwood, Arkansas, 72120, United States
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Anaheim, California, 92801, United States
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Lancaster, California, 93534, United States
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Mission Hills, California, 91345, United States
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Sacramento, California, 95821, United States
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San Diego, California, 92103, United States
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San Diego, California, 92120, United States
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Stanford, California, 94305, United States
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Westlake Village, California, 91361, United States
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Colorado Springs, Colorado, 80909, United States
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Lafayette, Colorado, 80026, United States
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Lakewood, Colorado, 80215, United States
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Littleton, Colorado, 80120, United States
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Milford, Connecticut, 06460, United States
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Waterbury, Connecticut, 06708, United States
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Jupiter, Florida, 33458, United States
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Pembroke Pines, Florida, 33024, United States
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Atlanta, Georgia, 30342, United States
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Clive, Iowa, 50325, United States
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Lexington, Kentucky, 40504, United States
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Madisonville, Kentucky, 42431, United States
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Baton Rouge, Louisiana, 70808, United States
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Metairie, Louisiana, 70006, United States
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Monroe, Louisiana, 71201, United States
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Shreveport, Louisiana, 71103, United States
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Annapolis, Maryland, 21401, United States
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Hagerstown, Maryland, 21742, United States
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Brockton, Massachusetts, 02301, United States
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Ann Arbor, Michigan, 48109, United States
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Egg Harbor, New Jersey, 08234, United States
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Binghamton, New York, 13903, United States
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Brooklyn, New York, 11214, United States
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Great Neck, New York, 11021, United States
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Johnson City, New York, 11042, United States
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Lake Success, New York, 11042, United States
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Charlotte, North Carolina, 28209, United States
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Fayetteville, North Carolina, 28304, United States
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Greensboro, North Carolina, 27403, United States
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Raleigh, North Carolina, 27612, United States
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Fargo, North Dakota, 58104, United States
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Columbus, Ohio, 43215, United States
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Norman, Oklahoma, 73071, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Uniontown, Pennsylvania, 15401, United States
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Chattanooga, Tennessee, 37421, United States
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Germantown, Tennessee, 38138, United States
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Bellaire, Texas, 77401, United States
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Lake Jackson, Texas, 77566, United States
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San Antonio, Texas, 78209, United States
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San Antonio, Texas, 78215, United States
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Logan, Utah, 84405, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84107, United States
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Charlottesville, Virginia, 22911, United States
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Christiansburg, Virginia, 24073, United States
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Waukesha, Wisconsin, 53188, United States
Unknown Facility
Guelph, Ontario, N1H 3R3, Canada
Unknown Facility
Toronto, Ontario, M3N 2V7, Canada
Related Publications (1)
Vakil NB, Huff FJ, Cundy KC. Randomised clinical trial: arbaclofen placarbil in gastro-oesophageal reflux disease--insights into study design for transient lower sphincter relaxation inhibitors. Aliment Pharmacol Ther. 2013 Jul;38(2):107-17. doi: 10.1111/apt.12363. Epub 2013 May 30.
PMID: 23721547DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
XenoPort, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 16, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 21, 2021
Record last verified: 2021-02