An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
NCT ID: NCT00557401
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
156 participants
INTERVENTIONAL
2007-11-30
2008-09-30
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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XP19986 SR3, 20 mg QD
XP19986, 20 mg QD for approximately 32 days
XP19986 SR3, 20 mg QD
XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 SR3, 40 mg QD
XP19986, 40 mg QD for approximately 32 days
XP19986 SR3, 40 mg QD
XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 SR3, 60 mg QD
XP19986, 60 mg QD for approximately 32 days
XP19986 SR3, 60 mg QD
XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 SR3, 30 mg BID
XP19986, 30 mg BID for approximately 32 days
XP19986 SR3, 30 mg BID
XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.
Placebo
Placebo for approximately 32 days
Placebo
Placebo tablet taken orally for approximately 32 days with titration and taper periods.
Interventions
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XP19986 SR3, 20 mg QD
XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 SR3, 40 mg QD
XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 SR3, 60 mg QD
XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 SR3, 30 mg BID
XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.
Placebo
Placebo tablet taken orally for approximately 32 days with titration and taper periods.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Jay Huff, M.D.
Role: STUDY_DIRECTOR
XenoPort, Inc.
Locations
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MDS Pharma Services
Irvine, California, United States
Countries
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Other Identifiers
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XP-B-057
Identifier Type: -
Identifier Source: org_study_id
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