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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978016

Enrollment

460

Registered

2009-09-16

Start date

2009-09-30

Completion date

2010-12-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Brief 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).

Interventions

DRUGarbaclofen 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

DRUGPlacebo-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

DRUGarbaclofen 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

DRUGarbaclofen 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

DRUGarbaclofen 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

DRUGPPI

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Heartburn Episodes	6 weeks	number of episodes

Secondary

Measure	Time frame	Description
Regurgitation Episodes	6 weeks	number of episodes

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026