Back to resultsAn Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XP19986 SR3, 20 mg QD
XP19986 SR3, 40 mg QD
XP19986 SR3, 60 mg QD
XP19986 SR3, 30 mg BID
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- History and documentation of GERD diagnosed by a gastroenterologist, with symptoms (heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and prior to randomization
Exclusion Criteria:
- Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D
Sites / Locations
- MDS Pharma Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
XP19986 SR3, 20 mg QD
XP19986 SR3, 40 mg QD
XP19986 SR3, 60 mg QD
XP19986 SR3, 30 mg BID
Placebo
Arm Description
XP19986, 20 mg QD for approximately 32 days
XP19986, 40 mg QD for approximately 32 days
XP19986, 60 mg QD for approximately 32 days
XP19986, 30 mg BID for approximately 32 days
Placebo for approximately 32 days
Outcomes
Primary Outcome Measures
Number of heartburn events over the treatment period
Secondary Outcome Measures
Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00557401
Brief Title
An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
Official Title
A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (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
To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XP19986 SR3, 20 mg QD
Arm Type
Experimental
Arm Description
XP19986, 20 mg QD for approximately 32 days
Arm Title
XP19986 SR3, 40 mg QD
Arm Type
Experimental
Arm Description
XP19986, 40 mg QD for approximately 32 days
Arm Title
XP19986 SR3, 60 mg QD
Arm Type
Experimental
Arm Description
XP19986, 60 mg QD for approximately 32 days
Arm Title
XP19986 SR3, 30 mg BID
Arm Type
Experimental
Arm Description
XP19986, 30 mg BID for approximately 32 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for approximately 32 days
Intervention Type
Drug
Intervention Name(s)
XP19986 SR3, 20 mg QD
Other Intervention Name(s)
arbaclofen placarbil
Intervention Description
XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
Intervention Type
Drug
Intervention Name(s)
XP19986 SR3, 40 mg QD
Other Intervention Name(s)
arbaclofen placarbil
Intervention Description
XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
Intervention Type
Drug
Intervention Name(s)
XP19986 SR3, 60 mg QD
Other Intervention Name(s)
arbaclofen placarbil
Intervention Description
XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
Intervention Type
Drug
Intervention Name(s)
XP19986 SR3, 30 mg BID
Other Intervention Name(s)
arbaclofen placarbil
Intervention Description
XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Placebo tablet taken orally for approximately 32 days with titration and taper periods.
Primary Outcome Measure Information:
Title
Number of heartburn events over the treatment period
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms
Time Frame
4-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:
History and documentation of GERD diagnosed by a gastroenterologist, with symptoms (heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and prior to randomization
Exclusion Criteria:
Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Huff, M.D.
Organizational Affiliation
XenoPort, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MDS Pharma Services
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
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