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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indivior Inc.; XenoPort, Inc.
• Treatments: Arbaclofen placarbil; Baclofen; Dexlansoprazole; Esomeprazole; Lansoprazole; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Rabeprazole

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