A Study to Evaluate the Efficacy and Safety of Arbaclofen... | NCT00978016 | Trialant

A Study to Evaluate the Efficacy and Safety of Arbaclofen... | NCT00978016 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
arbaclofen placarbil-Cohort 1	Experimental	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	Drug: arbaclofen placarbil-Cohort 1 Drug: PPI
arbaclofen placarbil-Cohort 2	Experimental	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	Drug: arbaclofen placarbil-Cohort 2 Drug: PPI
arbaclofen placarbil-Cohort 3	Experimental	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	Drug: arbaclofen placarbil-Cohort 3 Drug: PPI
arbaclofen placarbil-Cohort 4	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
arbaclofen placarbil-Cohort 1	Drug	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

Outcomes Module

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23721547	Derived	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.