Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-18 @ 1:34 AM
Study NCT ID:
NCT01827293
Status:
COMPLETED
Last Update Posted:
2013-06-14
First Post:
2013-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promethazine vs. Lorazepam for Treatment of Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011398', 'term': 'Promethazine'}, {'id': 'D008140', 'term': 'Lorazepam'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-13', 'studyFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in vertigo intensity.', 'timeFrame': 'At 2 hours after intervention.', 'description': 'The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications.'}], 'secondaryOutcomes': [{'measure': 'Efficacy and Safety outcome measures (nausea change-second dose-adverse events).', 'timeFrame': 'At 2-8 hours after intervention.', 'description': 'Secondary outcomes included, mean change in nausea VAS score, need for second dose of study medications, and the rate of drug-related adverse events for the subjects in each study group after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peripheral Vertigo.']}, 'descriptionModule': {'briefSummary': 'This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Background history of positional vertigo\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Pregnant or possibly pregnant\n* Known allergy to study medications\n* Use of antiemetic agents in the previous 24 hours\n* Evidence of drug-induced vertigo or orthostatic hypotension\n* Central pathologies/central origin for vertigo'}, 'identificationModule': {'nctId': 'NCT01827293', 'briefTitle': 'Promethazine vs. Lorazepam for Treatment of Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SB-067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Promethazine', 'description': 'IV promethazine (25 mg)', 'interventionNames': ['Drug: Promethazine', 'Drug: Lorazepam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lorazepam', 'description': 'IV lorazepam (2 mg)', 'interventionNames': ['Drug: Promethazine', 'Drug: Lorazepam']}], 'interventions': [{'name': 'Promethazine', 'type': 'DRUG', 'armGroupLabels': ['Promethazine', 'lorazepam']}, {'name': 'Lorazepam', 'type': 'DRUG', 'armGroupLabels': ['Promethazine', 'lorazepam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17666-33815', 'city': 'Tehran', 'state': 'Nezam Abad', 'country': 'Iran', 'facility': 'Department of Neurology, Emam Hossein Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Shadi Asadollahi', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}