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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.
ClinicalTrials.gov Identifier:
NCT00557401
First received: November 12, 2007
Last updated: December 30, 2015
Last verified: December 2015

November 12, 2007
December 30, 2015
November 2007
September 2008   (final data collection date for primary outcome measure)
Number of heartburn events over the treatment period [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
Number of heartburn events over the treatment period [ Time Frame: Treatment period ]
Complete list of historical versions of study NCT00557401 on ClinicalTrials.gov Archive Site
Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms [ Time Frame: Treatment period ]
Not Provided
Not Provided
 
An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroesophageal Reflux
  • Drug: XP19986 SR3, 20 mg QD
    After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
    Other Name: arbaclofen placarbil
  • Drug: XP19986 SR3, 40 mg QD
    After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
    Other Name: arbaclofen placarbil
  • Drug: XP19986 SR3, 60 mg QD
    After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
    Other Name: arbaclofen placarbil
  • Drug: XP19986 SR3, 30 mg BID
    After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
    Other Name: arbaclofen placarbil
  • Drug: Placebo
    After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
    Other Name: Sugar Pill
  • Experimental: XP19986 SR3, 20 mg QD
    XP19986, 20 mg QD
    Intervention: Drug: XP19986 SR3, 20 mg QD
  • Experimental: XP19986 SR3, 40 mg QD
    XP19986, 40 mg QD
    Intervention: Drug: XP19986 SR3, 40 mg QD
  • Experimental: XP19986 SR3, 60 mg QD
    XP19986, 60 mg QD
    Intervention: Drug: XP19986 SR3, 60 mg QD
  • Experimental: XP19986 SR3, 30 mg BID
    XP19986, 30 mg BID
    Intervention: Drug: XP19986 SR3, 30 mg BID
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00557401
XP-B-057
No
Not Provided
Not Provided
Indivior Inc.
Indivior Inc.
Not Provided
Study Director: Jay Huff, M.D. XenoPort, Inc.
Indivior Inc.
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP