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: June 23, 2014
Last verified: May 2014
  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-Cohort 1
Drug: Placebo-Cohort 5
Drug: arbaclofen placarbil-Cohort 2
Drug: arbaclofen placarbil-Cohort 3
Drug: arbaclofen placarbil-Cohort 4
Drug: PPI
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:


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: arbaclofen placarbil-Cohort 1

arbaclofen placarbil 20 mg QD with PPI*

* 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

Drug: arbaclofen placarbil-Cohort 1
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 Name: XP19986
Drug: PPI
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 Name: Proton Pump Inhibitor
Experimental: arbaclofen placarbil-Cohort 2

arbaclofen placarbil 40 mg QD with PPI*

* 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

Drug: arbaclofen placarbil-Cohort 2
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 Name: XP19986
Drug: PPI
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 Name: Proton Pump Inhibitor
Experimental: arbaclofen placarbil-Cohort 3

arbaclofen placarbil 20 mg BID with PPI*

* 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

Drug: arbaclofen placarbil-Cohort 3
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 Name: XP19986
Drug: PPI
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 Name: Proton Pump Inhibitor
Experimental: arbaclofen placarbil-Cohort 4

arbaclofen placarbil 30 mg BID with PPI*

* 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

Drug: arbaclofen placarbil-Cohort 4
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 Name: XP19986
Drug: PPI
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 Name: Proton Pump Inhibitor
Placebo Comparator: Placebo-Cohort 5

Placebo dose with PPI*

* 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

Drug: Placebo-Cohort 5
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 Name: XP19986 matching placebo
Drug: PPI
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 Name: Proton Pump Inhibitor

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by XenoPort, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by XenoPort, Inc.:
GERD

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

ClinicalTrials.gov processed this record on October 23, 2014