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

NCT00557401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-02-21

No results posted yet for this study

Summary

To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD

Conditions

  • Gastroesophageal Reflux

Interventions

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.

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.

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.

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.

DRUG

Placebo

Placebo tablet taken orally for approximately 32 days with titration and taper periods.

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • Jay Huff, M.D. · XenoPort, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557401 on ClinicalTrials.gov