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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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).

Key facts

Study ID

NCT00978016

Run by

XenoPort, Inc.

People needed

460

Starts

2009-09-01

Expected to finish

2010-12-01

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Sherwood, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Lancaster, California, United States
• Study site — Mission Hills, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Westlake Village, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Lafayette, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Milford, Connecticut, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Jupiter, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Clive, Iowa, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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