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

Vertigo Clinical Trial

— VERTIGO  

Official title:

To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213120
• Other study ID #: BETA5003
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: May 27, 2015
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Drug Regulatory Authority of Pakistan
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Locations

Country	Name	City	State
Pakistan	Research facility ID ORG-001139	Hyderabad
Pakistan	Research facility ID ORG-001053	Islamabad
Pakistan	Research facility ID ORG-001050	Karachi
Pakistan	Research facility ID ORG-001051	Karachi
Pakistan	Research facility ID ORG-001069	Karachi
Pakistan	Research facility ID ORG-001070	Karachi
Pakistan	Research facility ID ORG-001054	Lahore
Pakistan	Research facility ID ORG-001055	Lahore
Pakistan	Research facility ID ORG-001060	Lahore
Pakistan	Research facility ID ORG-001061	Lahore
Pakistan	Research facility ID ORG-001052	Peshawar

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Dimension Research

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics (Different Types) of dizziness	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	6 months	No
Secondary	Quality of Life (QoL) of patients at baselines	Dizziness Handicap Inventory will be used	6 months	No
Secondary	Management of vertigo currently in practice	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.	6 months	No
Secondary	QoL of patients post treatment	Dizziness Handicap Inventory will be used	6 months	No