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An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD

Sponsor
XenoPort, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00557401
Collaborator
(none)
156
Enrollment
1
Location
5
Arms
10
Duration (Months)
15.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: XP19986 SR3, 20 mg QD
  • Drug: XP19986 SR3, 40 mg QD
  • Drug: XP19986 SR3, 60 mg QD
  • Drug: XP19986 SR3, 30 mg BID
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: XP19986 SR3, 20 mg QD

XP19986, 20 mg QD for approximately 32 days

Drug: 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.
Other Names:
  • arbaclofen placarbil

    		•
    Experimental: XP19986 SR3, 40 mg QD

    XP19986, 40 mg QD for approximately 32 days

    Drug: 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.
    Other Names:
  • arbaclofen placarbil

    		•
    Experimental: XP19986 SR3, 60 mg QD

    XP19986, 60 mg QD for approximately 32 days

    Drug: 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.
    Other Names:
  • arbaclofen placarbil

    		•
    Experimental: XP19986 SR3, 30 mg BID

    XP19986, 30 mg BID for approximately 32 days

    Drug: 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.
    Other Names:
  • arbaclofen placarbil

    		•
    Placebo Comparator: Placebo

    Placebo for approximately 32 days

    Drug: Placebo
    Placebo tablet taken orally for approximately 32 days with titration and taper periods.
    Other Names:
  • Sugar Pill

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of heartburn events over the treatment period [4-weeks]

    Secondary Outcome Measures

    1. Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms [4-weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MDS Pharma Services Irvine California United States 92618

    Sponsors and Collaborators

    • XenoPort, Inc.

    Investigators

    • Study Director: Jay Huff, M.D., XenoPort, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    XenoPort, Inc.
    ClinicalTrials.gov Identifier:
    NCT00557401
    Other Study ID Numbers:
    • XP-B-057
    First Posted:
    Nov 14, 2007
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Arbaclofen placarbil
    Baclofen

    Study Results

    No Results Posted as of Feb 21, 2021