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To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics. (VERTIGO)

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ClinicalTrials.gov Identifier: NCT02213120
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Dimension Research
Information provided by (Responsible Party):
Abbott

Brief Summary:
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.

Condition or disease
Vertigo

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Dizziness
Patients with Dizziness



Primary Outcome Measures :
  1. Characteristics (Different Types) of dizziness [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Quality of Life (QoL) of patients at baselines [ Time Frame: 6 months ]
    Dizziness Handicap Inventory will be used

  2. Management of vertigo currently in practice [ Time Frame: 6 months ]
    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.

  3. QoL of patients post treatment [ Time Frame: 6 months ]
    Dizziness Handicap Inventory will be used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic/Private Clinic
Criteria

Inclusion Criteria:

  • Male or female patients 18 years of age and older
  • Patients with vestibular vertigo of known or unknown origin
  • Patients who are willing and able to provide written informed consent

Exclusion Criteria:

  • Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion based on clinical judgment
  • Patient with psychiatric disorders, significant neurological disorder or spinal cord damage that would make the evaluation difficult for the investigator
  • Patients who are not willing to give informed consent
  • Patients with a known history of hypersensitivity to betahistine
  • Patients with a history of pheochromocytoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213120


Locations
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Pakistan
Research facility ID ORG-001139
Hyderabad, Pakistan, 76090
Research facility ID ORG-001053
Islamabad, Pakistan, 44000
Research facility ID ORG-001070
Karachi, Pakistan, 75050
Research facility ID ORG-001051
Karachi, Pakistan, 75190
Research facility ID ORG-001069
Karachi, Pakistan, 75900
Research facility ID ORG-001050
Karachi, Pakistan, 75950
Research facility ID ORG-001060
Lahore, Pakistan, 54570
Research facility ID ORG-001054
Lahore, Pakistan, 54660
Research facility ID ORG-001055
Lahore, Pakistan, 54660
Research facility ID ORG-001061
Lahore, Pakistan, 54810
Research facility ID ORG-001052
Peshawar, Pakistan, 7041298
Sponsors and Collaborators
Abbott
Dimension Research
Investigators
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Study Director: Raeefuddin Ahmed, MD Abbott

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02213120     History of Changes
Other Study ID Numbers: BETA5003
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Abbott:
Vertigo, Dizziness
Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders