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)
1 other identifier
interventional
156
1 country
1
Brief Summary
To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 12, 2007
CompletedFirst Posted
Study publicly available on registry
November 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFebruary 21, 2021
February 1, 2021
10 months
November 12, 2007
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of heartburn events over the treatment period
4-weeks
Secondary Outcomes (1)
Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms
4-weeks
Study Arms (5)
XP19986 SR3, 20 mg QD
EXPERIMENTALXP19986, 20 mg QD for approximately 32 days
XP19986 SR3, 40 mg QD
EXPERIMENTALXP19986, 40 mg QD for approximately 32 days
XP19986 SR3, 60 mg QD
EXPERIMENTALXP19986, 60 mg QD for approximately 32 days
XP19986 SR3, 30 mg BID
EXPERIMENTALXP19986, 30 mg BID for approximately 32 days
Placebo
PLACEBO COMPARATORPlacebo for approximately 32 days
Interventions
XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.
Placebo tablet taken orally for approximately 32 days with titration and taper periods.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XenoPort, Inc.lead
Study Sites (1)
MDS Pharma Services
Irvine, California, 92618, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jay Huff, M.D.
XenoPort, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2007
First Posted
November 14, 2007
Study Start
November 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
February 21, 2021
Record last verified: 2021-02