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

XenoPort

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: arbaclofen placarbil-Cohort 2; Drug: Placebo-Cohort 5; Drug: arbaclofen placarbil-Cohort 3; Drug: arbaclofen placarbil-Cohort 4; Drug: PPI; Drug: arbaclofen placarbil-Cohort 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978016

XP-B-078

Details and patient eligibility

About

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).

Enrollment: 460 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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460 participants in 5 patient groups, including a placebo group

arbaclofen placarbil-Cohort 1

Experimental group

Description:

arbaclofen placarbil 20 mg QD with 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

Treatment:

Drug: arbaclofen placarbil-Cohort 1

Drug: PPI

arbaclofen placarbil-Cohort 2

Experimental group

Description:

arbaclofen placarbil 40 mg QD with 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

Treatment:

Drug: PPI

Drug: arbaclofen placarbil-Cohort 2

arbaclofen placarbil-Cohort 3

Experimental group

Description:

arbaclofen placarbil 20 mg BID with 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

Treatment:

Drug: PPI

Drug: arbaclofen placarbil-Cohort 3

arbaclofen placarbil-Cohort 4

Experimental group

Description:

arbaclofen placarbil 30 mg BID with 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

Treatment:

Drug: PPI

Drug: arbaclofen placarbil-Cohort 4

Placebo-Cohort 5

Placebo Comparator group

Description:

Placebo dose with 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

Treatment:

Drug: PPI

Drug: Placebo-Cohort 5