A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: GERD

In brief

The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil (XP19986) compared to placebo in patients with gastroesophageal reflux disease.

Key facts

Study ID

NCT00838396

Run by

Indivior Inc.

People needed

58

Starts

2005-10-01

Expected to finish

2006-08-01

Last updated by the study team

2016-09-14

Who can join

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

You may qualify if…

• History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week
• Discontinuation of drugs used to treat GERD (PPIs, H2-blockers) and/or drugs known to cause GERD symptoms (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs]) for 7 days prior to baseline (Visit 2);
• Had greater then or equal to 20 postprandial reflux episodes/2 hours recorded using impedance/pH monitoring during Screening/Baseline period (Visit 2)

You may not qualify if…

• History of gastrointestinal disorders other than GERD that may have significantly affected the assessment of reflux episodes or GERD symptoms (e.g. Barrett's Esophagus, active gastric or duodenal ulcer disease, achalasia, scleroderma, etc.).
• Medical conditions that could have affected assessments of reflux episodes or GERD symptoms (e.g. history of nausea and/or vomiting, neurologic/psychiatric disorders, cardiac disease [e.g. angina], lung disease [e.g. asthma, cough], etc.)

Where it is running

• Study site — Stanford, California, United States
• Study site — Charleston, South Carolina, United States
• Study site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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