Back to resultsA Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
arbaclofen placarbil-Cohort 1
Placebo-Cohort 5
arbaclofen placarbil-Cohort 2
arbaclofen placarbil-Cohort 3
arbaclofen placarbil-Cohort 4
PPI
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
arbaclofen placarbil-Cohort 1
arbaclofen placarbil-Cohort 2
arbaclofen placarbil-Cohort 3
arbaclofen placarbil-Cohort 4
Placebo-Cohort 5
Arm Description
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 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 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 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 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
Outcomes
Primary Outcome Measures
Heartburn Episodes
number of episodes
Secondary Outcome Measures
Regurgitation Episodes
number of episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00978016
Brief Title
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XenoPort, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arbaclofen placarbil-Cohort 1
Arm Type
Experimental
Arm Description
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
Arm Title
arbaclofen placarbil-Cohort 2
Arm Type
Experimental
Arm Description
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
Arm Title
arbaclofen placarbil-Cohort 3
Arm Type
Experimental
Arm Description
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
Arm Title
arbaclofen placarbil-Cohort 4
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo-Cohort 5
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
arbaclofen placarbil-Cohort 1
Other Intervention Name(s)
XP19986
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo-Cohort 5
Other Intervention Name(s)
XP19986 matching placebo
Intervention Description
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods
Intervention Type
Drug
Intervention Name(s)
arbaclofen placarbil-Cohort 2
Other Intervention Name(s)
XP19986
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
arbaclofen placarbil-Cohort 3
Other Intervention Name(s)
XP19986
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
arbaclofen placarbil-Cohort 4
Other Intervention Name(s)
XP19986
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PPI
Other Intervention Name(s)
Proton Pump Inhibitor
Intervention Description
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
Primary Outcome Measure Information:
Title
Heartburn Episodes
Description
number of episodes
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Regurgitation Episodes
Description
number of episodes
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
XenoPort, Inc.
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85203
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13903
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
Johnson City
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Logan
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 3R3
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23721547
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
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