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OpenTrials
Completed

NCT Number: NCT00557401

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

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

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MDS Pharma Services

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XP19986 SR3, 20 mg QD

Drug

XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.

Other names: arbaclofen placarbil

XP19986 SR3, 40 mg QD

Drug

XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.

Other names: arbaclofen placarbil

XP19986 SR3, 60 mg QD

Drug

XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.

Other names: arbaclofen placarbil

XP19986 SR3, 30 mg BID

Drug

XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.

Other names: arbaclofen placarbil

Placebo

Drug

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

Other names: Sugar Pill

Primary outcomes

  1. Number of heartburn events over the treatment period

    Time frame: 4-weeks

Secondary outcomes

  1. Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms

    Time frame: 4-weeks

Sponsors and collaborators

Lead sponsor

XenoPort, Inc.

Industry

Registry information

Official study title

A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 14, 2007
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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