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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00978016
First received: September 11, 2009
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
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 ]

Enrollment: 425
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
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
Experimental: Cohort 2
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
Experimental: Cohort 3
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
Experimental: Cohort 4
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
Placebo Comparator: Cohort 5
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:

  1. confirmed diagnosis of GERD by a gastroenterologist
  2. minimum of 3 months of GERD symptoms prior to screening.
  3. currently taking an FDA approved dose of PPI therapy for symptomatic GERD for at least 4 weeks prior to screening
  4. experienced partial relief of GERD symptoms while receiving approved dose and regimen of PPI therapy
  5. 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:

  1. evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal endoscopy during screening
  2. has not experienced any GERD symptom improvement after an adequate course of PPI treatment (at least 2 weeks)
  3. unstable or severe medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978016

  Show 64 Study Locations
Sponsors and Collaborators
XenoPort, Inc.
Investigators
Study Director: Study Director XenoPort, Inc.
  More Information

Additional Information:
Study Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT00978016     History of Changes
Other Study ID Numbers: XP-B-078
Study First Received: September 11, 2009
Last Updated: January 27, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by XenoPort, Inc.:
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Baclofen
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013