NCT00557401

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-11-14
• Last updated: 2021-02-21

Locations

1 site across 1 country: United States