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

Gastroesophageal Reflux Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978016
• Other study ID #: XP-B-078
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2021
• Source: XenoPort, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• arbaclofen placarbil-Cohort 1
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 5
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 2
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 3
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 4
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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XenoPort, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heartburn Episodes	number of episodes	6 weeks
Secondary	Regurgitation Episodes	number of episodes	6 weeks