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Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome

NCT02090504 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2014-03-18

No results posted yet for this study

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).

Conditions

  • Alcohol Withdrawal Syndrome
  • Alcohol Dependence

Interventions

DRUG

Sodium Oxybate (SMO)

DRUG

Oxazepam

Sponsors & Collaborators

  • CT Pharmaceutical Industries, Sanremo - Italy

    collaborator UNKNOWN

  • University of Bologna

    collaborator OTHER

  • Medical University of Vienna

    collaborator OTHER

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Otto Lesch, MD, Prof. · Department of Psychiatry, University of Wien

  • Giovanni Addolorato, MD · Department of Internal Medicine, Catholic University of Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • Austria
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02090504 on ClinicalTrials.gov