Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-25 @ 5:39 AM
Study NCT ID:
NCT02213120
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2014-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D004244', 'term': 'Dizziness'}], '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'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2014-08-08', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics (Different Types) of dizziness', 'timeFrame': '6 months', 'description': "It will be determined that a patient with dizziness is suffering from what type of Vertigo i.e. Benign Paroxysmal Positional Vertigo, Menier's Disease, Vestibular Neuritis, Labyrinthitis or any other. As these are clinical types of Vertigo these cannot be measured in units"}], 'secondaryOutcomes': [{'measure': 'Quality of Life (QoL) of patients at baselines', 'timeFrame': '6 months', 'description': 'Dizziness Handicap Inventory will be used'}, {'measure': 'Management of vertigo currently in practice', 'timeFrame': '6 months', 'description': "As per practice of the physician/Investigator. Management of Vertigo is either by certain maneuvers such as Epley's and Simont or by medications. For the maneuvers, no unit can be defined. The information for medication which will be collected will be Name (preferably the generic name), Dose, Units (form of the medicine), Route and Frequency."}, {'measure': 'QoL of patients post treatment', 'timeFrame': '6 months', 'description': 'Dizziness Handicap Inventory will be used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vertigo, Dizziness'], 'conditions': ['Vertigo']}, 'descriptionModule': {'briefSummary': 'The VERTIGO study is likely to help determine characteristics of different types of vertigo in patients presenting in the Ear Nose \\& Throat (ENT) clinics with complaints of dizziness. Moreover, it will also help to develop an understanding about the current management practices of this condition at local level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic/Private Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients 18 years of age and older\n* Patients with vestibular vertigo of known or unknown origin\n* Patients who are willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion based on clinical judgment\n* Patient with psychiatric disorders, significant neurological disorder or spinal cord damage that would make the evaluation difficult for the investigator\n* Patients who are not willing to give informed consent\n* Patients with a known history of hypersensitivity to betahistine\n* Patients with a history of pheochromocytoma'}, 'identificationModule': {'nctId': 'NCT02213120', 'acronym': 'VERTIGO', 'briefTitle': 'To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.', 'orgStudyIdInfo': {'id': 'BETA5003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dizziness', 'description': 'Patients with Dizziness'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76090', 'city': 'Hyderābād', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001139', 'geoPoint': {'lat': 25.39689, 'lon': 68.37718}}, {'zip': '44000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001053', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '75050', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001070', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '75190', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001051', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '75900', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001069', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '75950', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001050', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '54570', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001060', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54660', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001054', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54660', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001055', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54810', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001061', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '7041298', 'city': 'Peshawar', 'country': 'Pakistan', 'facility': 'Research facility ID ORG-001052', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Raeefuddin Ahmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dimension Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}