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

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00557401
First received: November 12, 2007
Last updated: September 10, 2010
Last verified: September 2010

November 12, 2007
September 10, 2010
December 2007
October 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, 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
  • Drug: XP19986, 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
  • Drug: XP19986, 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
  • Drug: XP19986, 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
  • Drug: XP19986 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
  • Experimental: 1
    Intervention: Drug: XP19986, 20 mg QD
  • Experimental: 2
    Intervention: Drug: XP19986, 40 mg QD
  • Experimental: 3
    Intervention: Drug: XP19986, 60 mg QD
  • Experimental: 4
    Intervention: Drug: XP19986, 30 mg BID
  • Experimental: 5
    Intervention: Drug: XP19986 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
October 2008
October 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 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00557401
XP-B-057
Not Provided
Jay Huff, VP Clinical Development, XenoPort Inc
XenoPort, Inc.
Not Provided
Study Director: Jay Huff, M.D. XenoPort, Inc.
XenoPort, Inc.
September 2010

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