Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-25 @ 2:34 AM
Study NCT ID:
NCT02090504
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012978', 'term': 'Sodium Oxybate'}, {'id': 'D010076', 'term': 'Oxazepam'}], 'ancestors': [{'id': 'D006885', 'term': 'Hydroxybutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Craving for study drug.', 'timeFrame': 'day 1, day 10, day 20', 'description': 'Assessment of craving for the study drug.'}], 'primaryOutcomes': [{'measure': 'Efficacy of GHB compared to oxazepam on alcohol withdrawal symptoms', 'timeFrame': 'day 1, day 10, day 20', 'description': 'The primary outcome was the reduction of symptoms of AWS reflected by the course of the total CIWA-Ar scores from the start (baseline) to the end of the study (day 10) and to the end of follow up (day 20, 10 days after drugs discontinuation).'}], 'secondaryOutcomes': [{'measure': 'Course of alcohol abstinence', 'timeFrame': 'day 1, day 10, day 20', 'description': 'Secondary outcome variables included the course of alcohol abstinence. In order to confirm daily alcohol abstinence, a breath analyzer was used. In addition, to define those subjects remaining abstinent throughout the whole treatment period, carbohydrate-deficient transferrin (%CDT) was evaluated at the time of screening and at the end of the treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alcohol withdrawal syndrome', 'treatment', 'sodium oxybate', 'oxazepam'], 'conditions': ['Alcohol Withdrawal Syndrome', 'Alcohol Dependence']}, 'referencesModule': {'references': [{'pmid': '24283802', 'type': 'BACKGROUND', 'citation': 'Skala K, Caputo F, Mirijello A, Vassallo G, Antonelli M, Ferrulli A, Walter H, Lesch O, Addolorato G. Sodium oxybate in the treatment of alcohol dependence: from the alcohol withdrawal syndrome to the alcohol relapse prevention. Expert Opin Pharmacother. 2014 Feb;15(2):245-57. doi: 10.1517/14656566.2014.863278. Epub 2013 Nov 28.'}, {'pmid': '24996524', 'type': 'DERIVED', 'citation': 'Caputo F, Skala K, Mirijello A, Ferrulli A, Walter H, Lesch O, Addolorato G. Sodium oxybate in the treatment of alcohol withdrawal syndrome: a randomized double-blind comparative study versus oxazepam. The GATE 1 trial. CNS Drugs. 2014 Aug;28(8):743-52. doi: 10.1007/s40263-014-0183-1.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'This is a phase IV, multicenter randomized (1:1), 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.\n\nA placebo-controlled design was considered but excluded, given that a gold standard treatment for AWS is available (i.e., BDZs).\n\nFurthermore, considering that SMO and oxazepam have two different pharmaceutical formulation (suspension and tablets, respectively), a double-dummy design was adopted.\n\nThus, all subjects will receive both medications, tablets (oxazepam or placebo) and suspension (SMO or placebo), at the same time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age range 21-75,\n* diagnosis of alcohol dependence according to DSM-IV criteria\n* the presence of AWS as assessed by Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) scale, a scoring system for quantitative evaluation of physical symptoms of AWS.20 Only subjects with a CIWA-Ar score equal to or higher than 10 (defined as moderate or severe AWS requiring pharmacological treatment) were ultimately enrolled in the study.\n\nExclusion criteria:\n\n* ≤55 kg of body weight;\n* history of withdrawal fits within 24 hours pre-study;\n* history of epilepsy or epileptics seizures not properly controlled by established anti-epileptic treatment;\n* dependence from narcotics, BDZs or other drugs of abuse;\n* documented pre-existent hypersensitivity to SMO or to BDZs,\n* renal failure (blood creatinine \\>2•5 mg/dl and/or documented proteinuria \\>500 mg/die),\n* heart failure,\n* severe respiratory failure\n* hepatic encephalopathy stage II-IV;\n* psychiatric disorders requiring treatment with psychoactive medications before the start of the study;\n* treatment with clonidine, haloperidol, bromocriptine during the last 3 months prior to participation in the study;\n* participation to other clinical investigations in the previous month prior to recruitment;\n* females whose could not assure not to become pregnant during the 1 month period of treatment, and during the subsequent 3 weeks;\n* subjects without a stable social condition or homeless.'}, 'identificationModule': {'nctId': 'NCT02090504', 'acronym': 'GATE I', 'briefTitle': 'Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'The Gamma Hydroxybutyric Acid in Alcohol-dependence Treatment Efficacy (GATE) I Trial: a Comparative Study Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome', 'orgStudyIdInfo': {'id': 'GATE-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium oxybate (SMO)', 'description': "Patients randomized to the first arm of the study will receive:\n\n* SMO (sodium oxybate 175 mg/ml suspension): 10ml at 8.00 a.m., 10ml at 12.00 p.m., 10ml at 7.00 p.m. from day 1 to day 5, 5ml at 8.00 a.m., 5ml at 12.00 p.m., 5ml at 7.00 pm, on days 6 and 7, and 2.5ml at 8.00 a.m., 2.5 ml at 12.00 p.m., 2.5ml at 7.00 p.m. from day 8 to day 10 (If patient's weight is \\> 75 kg the dosage will be of 12ml instead of 10 ml, 6ml instead of 5ml, 3 ml instead of 2.5ml);\n* placebo (tablets): 1 tablet at 8.00 a.m., 1 tablet at 12.00 p.m., 1 tablet at 7.00 p.m. from day 1 to day 10.", 'interventionNames': ['Drug: Sodium Oxybate (SMO)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxazepam', 'description': "Patients randomized to the second arm of the study will receive:\n\n* OXAZEPAM (tablets): 60mg at 8.00 a.m., 60mg at 12.00 p.m., 90mg at 7.00 p.m. from day 1 to day 5, 30mg at 8.00 a.m., 30mg at 12.00 p.m., 30mg at 7.00 pm, on days 6 and 7, and 15mg at 8.00 a.m., 15mg at 12.00 p.m., 15mg at 7.00 p.m. from day 8 to day 10;\n* placebo (suspension): 10ml at 8.00 a.m., 10ml at 12.00 p.m., 10ml at 7.00 p.m. from day 1 to day 5, 5ml at 8.00 a.m., 5ml at 12.00 p.m., 5ml at 7.00 pm, on days 6 and 7, and 2.5ml at 8.00 a.m., 2.5 ml at 12.00 p.m., 2.5ml at 7.00 p.m. from day 8 to day 10, (If patient's weight is \\> 75 kg the dosage will be of 12ml instead of 10 ml, 6ml instead of 5ml, 3 ml instead of 2.5ml).", 'interventionNames': ['Drug: Oxazepam']}], 'interventions': [{'name': 'Sodium Oxybate (SMO)', 'type': 'DRUG', 'otherNames': ['Gamma-hydroxy butyrate (GHB)'], 'armGroupLabels': ['Sodium oxybate (SMO)']}, {'name': 'Oxazepam', 'type': 'DRUG', 'armGroupLabels': ['Oxazepam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'state': 'AT', 'country': 'Austria', 'facility': 'University of Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': '"G. Fontana" Centre for the Study and Multidisciplinary Treatment of Alcohol Addiction, Department of Clinical Medicine, University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '00168', 'city': 'Rome', 'state': 'Rm', 'country': 'Italy', 'facility': 'Catholic University of Rome', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Otto Lesch, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, University of Wien'}, {'name': 'Giovanni Addolorato, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Internal Medicine, Catholic University of Rome'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'collaborators': [{'name': 'CT Pharmaceutical Industries, Sanremo - Italy', 'class': 'UNKNOWN'}, {'name': 'University of Bologna', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine', 'investigatorFullName': 'Giovanni Addolorato', 'investigatorAffiliation': 'Catholic University, Italy'}}}}