Skip to main content
OpenTrials
Completed

NCT Number: NCT00978016

A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)

The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guelph, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed diagnosis of GERD by a gastroenterologist
  • minimum of 3 months of GERD symptoms prior to screening.
  • currently taking an FDA approved dose of PPI therapy for symptomatic GERD for at least 4 weeks prior to screening
  • experienced partial relief of GERD symptoms while receiving approved dose and regimen of PPI therapy
  • experienced GERD symptoms, defined as heartburn (with or without regurgitation or other GERD symptoms) on ≥ 3 days during the week prior to screening

Exclusion criteria

  • evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal endoscopy during screening
  • has not experienced any GERD symptom improvement after an adequate course of PPI treatment (at least 2 weeks)
  • unstable or severe medical condition

Treatment and study plan

arbaclofen placarbil-Cohort 1

Drug

After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg QD) for 7 weeks including titration and taper periods

Other names: XP19986

Placebo-Cohort 5

Drug

After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods

Other names: XP19986 matching placebo

arbaclofen placarbil-Cohort 2

Drug

After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 40 mg QD) with for 7 weeks including titration and taper periods

Other names: XP19986

arbaclofen placarbil-Cohort 3

Drug

After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg BID) for 7 weeks including titration and taper periods

Other names: XP19986

arbaclofen placarbil-Cohort 4

Drug

After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 30 mg BID) for 7 weeks including titration and taper periods

Other names: XP19986

PPI

Drug

Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD

Other names: Proton Pump Inhibitor

Primary outcomes

  1. Heartburn Episodes

    Time frame: 6 weeks

    number of episodes

Secondary outcomes

  1. Regurgitation Episodes

    Time frame: 6 weeks

    number of episodes

Sponsors and collaborators

Lead sponsor

XenoPort, Inc.

Industry

Registry information

Official study title

A Dose-Response Efficacy and Safety Study of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) Who Are Incomplete Responders to a Proton Pump Inhibitor (PPI)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2009
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.