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

Phase 2 Completed 460 enrolled XenoPort, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2009-09
Primary completion: 2010-12
Completion: 2010-12

Outcome

Missed primary endpoint

paper In the primary analysis, there was no significant difference between arbaclofen placarbil and placebo. PMID 23721547 ↗

Publications

Vakil NB, Huff FJ, Cundy KC. Randomised clinical trial: arbaclofen placarbil in gastro-oesophageal reflux disease--insights into study design for transient lower sphincter relaxation inhibitors. Aliment Pharmacol Ther. 2013 Jul;38(2):107-17. doi: 10.1111/apt.12363. Epub 2013 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Arbaclofen Placarbil	Small molecule	20 mg	—
Subject	Arbaclofen Placarbil	Small molecule	30 mg	—
Subject	Arbaclofen Placarbil	Small molecule	40 mg	—
Background	Dexlansoprazole	Other / unclassified	30 mg	—
Background	Dexlansoprazole	Other / unclassified	60 mg	—
Background	Esomeprazole	Small molecule	20 mg	—
Background	Esomeprazole	Small molecule	40 mg	—
Background	Lansoprazole	Other / unclassified	15 mg	—
Background	Lansoprazole	Other / unclassified	30 mg	—
Background	Omeprazole	Other / unclassified	20 mg	—
Background	Omeprazole	Other / unclassified	40 mg	—
Background	Omeprazole/sodium bicarbonate	Unknown	20 mg	—
Background	Omeprazole/sodium bicarbonate	Unknown	40 mg	—
Background	Pantoprazole	Other / unclassified	20 mg	—
Background	Pantoprazole	Other / unclassified	40 mg	—
Background	Rabeprazole	Small molecule	20 mg	—