Gastroesophageal Reflux DiseasePhase 2NCT00978016
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
A Phase 2 study testing arbaclofen placarbil-Cohort 1, arbaclofen placarbil-Cohort 2 and arbaclofen placarbil-Cohort 3 in people with Gastroesophageal Reflux Disease, run by XenoPort, Inc. at 64 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- arbaclofen placarbil-Cohort 1, arbaclofen placarbil-Cohort 2 and arbaclofen placarbil-Cohort 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 64 sitesin 2 countries
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
64 sites in 2 countries.
64 sites in 2 countries
United States62 sites
Study site
Anaheim, California, 92801
Study site
Ann Arbor, Michigan, 48109
Study site
Annapolis, Maryland, 21401
Study site
Atlanta, Georgia, 30342
Study site
Baton Rouge, Louisiana, 70808
Study site
Bellaire, Texas, 77401
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Binghamton, New York, 13903
Study site
Brockton, Massachusetts, 02301
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Brooklyn, New York, 11214
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Chandler, Arizona, 85224
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Charlotte, North Carolina, 28209
Study site
Charlottesville, Virginia, 22911
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Chattanooga, Tennessee, 37421
Study site
Christiansburg, Virginia, 24073
Study site
Clive, Iowa, 50325
Study site
Colorado Springs, Colorado, 80909
Study site
Columbus, Ohio, 43215
Study site
Egg Harbor, New Jersey, 08234
Study site
Fargo, North Dakota, 58104
Study site
Fayetteville, North Carolina, 28304
Study site
Germantown, Tennessee, 38138
Study site
Great Neck, New York, 11021
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Greensboro, North Carolina, 27403
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Hagerstown, Maryland, 21742
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Huntsville, Alabama, 35801
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Johnson City, New York, 11042
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Jupiter, Florida, 33458
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Lafayette, Colorado, 80026
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Lake Jackson, Texas, 77566
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Lake Success, New York, 11042
Study site
Lakewood, Colorado, 80215
Study site
Lancaster, California, 93534
Study site
Lexington, Kentucky, 40504
Study site
Littleton, Colorado, 80120
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Logan, Utah, 84405
Study site
Madisonville, Kentucky, 42431
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Mesa, Arizona, 85203
Study site
Mesa, Arizona, 85213
Study site
Metairie, Louisiana, 70006
Study site
Milford, Connecticut, 06460
Study site
Mission Hills, California, 91345
Study site
Monroe, Louisiana, 71201
Study site
Norman, Oklahoma, 73071
Study site
Ogden, Utah, 84405
Study site
Pembroke Pines, Florida, 33024
Study site
Pittsburgh, Pennsylvania, 15243
Study site
Raleigh, North Carolina, 27612
Study site
Sacramento, California, 95821
Study site
Salt Lake City, Utah, 84107
Study site
San Antonio, Texas, 78209
Study site
San Antonio, Texas, 78215
Study site
San Diego, California, 92103
Study site
San Diego, California, 92120
Study site
Scottsdale, Arizona, 85251
Study site
Sherwood, Arkansas, 72120
Study site
Shreveport, Louisiana, 71103
Study site
Stanford, California, 94305
Study site
Tucson, Arizona, 85715
Study site
Uniontown, Pennsylvania, 15401
Study site
Waterbury, Connecticut, 06708
Study site
Waukesha, Wisconsin, 53188
Study site
Westlake Village, California, 91361
Canada2 sites
Study site
Guelph, Ontario, N1H 3R3
Study site
Toronto, Ontario, M3N 2V7
About this study
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)
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).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- arbaclofen placarbil-Cohort 1, Placebo-Cohort 5, arbaclofen placarbil-Cohort 2, arbaclofen placarbil-Cohort 3, arbaclofen placarbil-Cohort 4
- Keywords
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arbaclofen placarbil-Cohort 1Drug
Also called XP19986
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
Placebo-Cohort 5Drug
Also called XP19986 matching placebo
After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods
arbaclofen placarbil-Cohort 2Drug
Also called XP19986
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
arbaclofen placarbil-Cohort 3Drug
Also called XP19986
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
arbaclofen placarbil-Cohort 4Drug
Also called XP19986
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
PPIDrug
Also called Proton Pump Inhibitor
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
| Study group | Role | What they receive |
|---|---|---|
| arbaclofen placarbil-Cohort 1 | Experimental | 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 Receives: Drug: arbaclofen placarbil-Cohort 1; Drug: PPI |
| arbaclofen placarbil-Cohort 2 | Experimental | 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 Receives: Drug: arbaclofen placarbil-Cohort 2; Drug: PPI |
| arbaclofen placarbil-Cohort 3 | Experimental | 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 Receives: Drug: arbaclofen placarbil-Cohort 3; Drug: PPI |
| arbaclofen placarbil-Cohort 4 | Experimental | 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 Receives: Drug: arbaclofen placarbil-Cohort 4; Drug: PPI |
| Placebo-Cohort 5 | Placebo comparator | 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 Receives: Drug: Placebo-Cohort 5; Drug: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heartburn Episodes
number of episodes
Measured: 6 weeks
Secondary outcomes (1)
Regurgitation Episodes
number of episodes
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, XenoPort, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978016
- Sponsor's protocol ID
- XP-B-078
- Status last verified
- Feb 2021
- First submitted
- 11 Sep 2009
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23721547
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00978016
- Acronym / sponsor ID
- XP-B-078
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| arbaclofen placarbil-Cohort 1 | Experimental | Drug: arbaclofen placarbil-Cohort 1, Drug: PPIarbaclofen 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 |
| arbaclofen placarbil-Cohort 2 | Experimental | Drug: arbaclofen placarbil-Cohort 2, Drug: PPIarbaclofen 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 |
| arbaclofen placarbil-Cohort 3 | Experimental | Drug: arbaclofen placarbil-Cohort 3, Drug: PPIarbaclofen 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 |
| arbaclofen placarbil-Cohort 4 | Experimental | Drug: arbaclofen placarbil-Cohort 4, Drug: PPIarbaclofen 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 |
| Placebo-Cohort 5 | Placebo comparator | Drug: Placebo-Cohort 5, Drug: PPIPlacebo 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arbaclofen placarbil-Cohort 1Also: XP19986After 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 | Drug | arbaclofen placarbil-Cohort 1 |
| Placebo-Cohort 5Also: XP19986 matching placeboAfter the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods | Drug | Placebo-Cohort 5 |
| arbaclofen placarbil-Cohort 2Also: XP19986After 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 | Drug | arbaclofen placarbil-Cohort 2 |
| arbaclofen placarbil-Cohort 3Also: XP19986After 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 | Drug | arbaclofen placarbil-Cohort 3 |
| arbaclofen placarbil-Cohort 4Also: XP19986After 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 | Drug | arbaclofen placarbil-Cohort 4 |
| PPIAlso: Proton Pump InhibitorAllowable 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, arbaclofen placarbil-Cohort 1, arbaclofen placarbil-Cohort 2, arbaclofen placarbil-Cohort 3, arbaclofen placarbil-Cohort 4 |
Primary outcome
Heartburn Episodes
Time frame: 6 weeks
number of episodes
1 secondary outcome
Regurgitation Episodes
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 23721547Vakil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
XenoPort, Inc.
64 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arbaclofen placarbil-Cohort 1, arbaclofen placarbil-Cohort 2 and arbaclofen placarbil-Cohort 3 in people with Gastroesophageal Reflux Disease, run by XenoPort, Inc. at 64 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heartburn Episodes (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00978016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.