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

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ClinicalTrials.gov Identifier: NCT00978016

Recruitment Status : Completed

First Posted : September 16, 2009

Last Update Posted : February 2, 2016

Sponsor:

Information provided by (Responsible Party):

Indivior Inc.

Study Description

Brief Summary:

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 or disease	Intervention/treatment	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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	460 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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)
Study Start Date :	September 2009
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Heartburn Episodes [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

Regurgitation Episodes [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978016

Show 64 Study Locations

Sponsors and Collaborators

Indivior Inc.

Investigators


Study Director:	Study Director	XenoPort, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vakil NB, Huff FJ, Cundy KC. Randomised clinical trial: arbaclofen placarbil in gastro-oesophageal reflux disease--insights into study design for transient lower sphincter relaxation inhibitors. Aliment Pharmacol Ther. 2013 Jul;38(2):107-17. doi: 10.1111/apt.12363. Epub 2013 May 30.


Responsible Party:	Indivior Inc.
ClinicalTrials.gov Identifier:	NCT00978016 History of Changes
Other Study ID Numbers:	XP-B-078
First Posted:	September 16, 2009 Key Record Dates
Last Update Posted:	February 2, 2016
Last Verified:	December 2015

Keywords provided by Indivior Inc.:


GERD

Additional relevant MeSH terms:


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

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