Clinical trial NCT00978016: A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Heartburn Episodes
timeFrame: 6 weeks
Secondary outcomes:
measure: Regurgitation Episodes
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Sherwood
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Lafayette
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Milford
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Jupiter
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Clive
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Madisonville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Monroe
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Egg Harbor Township
country: United States
state: New Jersey
city: Binghamton
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Columbus
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Pittsburgh
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Bellaire
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Logan
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Christiansburg
country: United States
state: Virginia
city: Waukesha
country: United States
state: Wisconsin
city: Guelph
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: XenoPort, Inc.
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.