A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT00978016
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
460 participants
INTERVENTIONAL
2009-09-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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arbaclofen placarbil-Cohort 1
arbaclofen 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 1
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
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
arbaclofen 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 2
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
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
arbaclofen 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 3
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
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
arbaclofen 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
arbaclofen placarbil-Cohort 4
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
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 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
Placebo-Cohort 5
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods
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
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arbaclofen placarbil-Cohort 1
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
Placebo-Cohort 5
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods
arbaclofen placarbil-Cohort 2
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
arbaclofen placarbil-Cohort 3
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
arbaclofen placarbil-Cohort 4
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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XenoPort, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
XenoPort, Inc.
Locations
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Huntsville, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Sherwood, Arkansas, United States
Anaheim, California, United States
Lancaster, California, United States
Mission Hills, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
Stanford, California, United States
Westlake Village, California, United States
Colorado Springs, Colorado, United States
Lafayette, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Milford, Connecticut, United States
Waterbury, Connecticut, United States
Jupiter, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Clive, Iowa, United States
Lexington, Kentucky, United States
Madisonville, Kentucky, United States
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
Monroe, Louisiana, United States
Shreveport, Louisiana, United States
Annapolis, Maryland, United States
Hagerstown, Maryland, United States
Brockton, Massachusetts, United States
Ann Arbor, Michigan, United States
Egg Harbor, New Jersey, United States
Binghamton, New York, United States
Brooklyn, New York, United States
Great Neck, New York, United States
Johnson City, New York, United States
Lake Success, New York, United States
Charlotte, North Carolina, United States
Fayetteville, North Carolina, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Norman, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Bellaire, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Logan, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Christiansburg, Virginia, United States
Waukesha, Wisconsin, United States
Guelph, Ontario, Canada
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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XP-B-078
Identifier Type: -
Identifier Source: org_study_id
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