Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02090504
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2014-03-17
Brief Title:
Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
The Gamma Hydroxybutyric Acid in Alcohol-dependence Treatment Efficacy GATE I Trial a Comparative Study Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GATE I
Brief Summary:
Benzodiazepines BDZs are the gold standard in the treatment of alcohol withdrawal syndrome AWS Gamma-Hydroxybutyric acid also known as sodium oxybate SMO has been tested as a treatment for AWS with encouraging results Aim of this phase IV multicenter randomized double-blind double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam in the treatment of alcohol withdrawal symptoms AWS
Detailed Description:
This is a phase IV multicenter randomized 11 active drug-controlled study double-blind double dummy with parallel groups evaluating the efficacy of SMO versus oxazepam in the treatment of AWS in alcohol-dependent patients
A placebo-controlled design was considered but excluded given that a gold standard treatment for AWS is available ie BDZs
Furthermore considering that SMO and oxazepam have two different pharmaceutical formulation suspension and tablets respectively a double-dummy design was adopted
Thus all subjects will receive both medications tablets oxazepam or placebo and suspension SMO or placebo at the same time
A placebo-controlled design was considered but excluded given that a gold standard treatment for AWS is available ie BDZs
Furthermore considering that SMO and oxazepam have two different pharmaceutical formulation suspension and tablets respectively a double-dummy design was adopted
Thus all subjects will receive both medications tablets oxazepam or placebo and suspension SMO or placebo at the same time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None