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

Sponsor:	XenoPort, Inc.
Information provided by:	XenoPort, Inc.
ClinicalTrials.gov Identifier:	NCT00978016

Purpose

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).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: arbaclofen placarbil Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official 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)

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Arbaclofen placarbil

U.S. FDA Resources

Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:

Heartburn Episodes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Regurgitation Episodes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	425
Study Start Date:	September 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental 20 mg QD	Drug: arbaclofen placarbil After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil or placebo) with PPI for 7 weeks including titration and taper periods
Cohort 2: Experimental 40 mg QD	Drug: arbaclofen placarbil After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil or placebo) with PPI for 7 weeks including titration and taper periods
Cohort 3: Experimental 20 mg BID	Drug: arbaclofen placarbil After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil or placebo) with PPI for 7 weeks including titration and taper periods
Cohort 4: Experimental 30 mg BID	Drug: arbaclofen placarbil After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil or placebo) with PPI for 7 weeks including titration and taper periods
Cohort 5: Placebo Comparator Placebo dose	Drug: Placebo After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil or placebo) with PPI for 7 weeks including titration and taper periods

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978016

Contacts

Contact: Study Manager

910-558-2856

Show 58 Study Locations

Sponsors and Collaborators

XenoPort, Inc.

Investigators

Study Director:

Study Director

XenoPort, Inc.

More Information

No publications provided

Responsible Party:	XenoPort, Inc. ( Study Director )
Study ID Numbers:	XP-B-078
Study First Received:	September 11, 2009
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00978016 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by XenoPort, Inc.:

GERD

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

Gastrointestinal Diseases
Enzyme Inhibitors
Esophageal Diseases
Gastroesophageal Reflux
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010