NCT02213120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

August 8, 2014

Last Update Submit

May 27, 2015

Conditions

Keywords

Vertigo, Dizziness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Quality of Life (QoL) of patients at baselines

    6 months

  • Management of vertigo currently in practice

    6 months

  • QoL of patients post treatment

    6 months

Study Arms (1)

Dizziness

Patients with Dizziness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic/Private Clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research facility ID ORG-001139

Hyderābād, 76090, Pakistan

Location

Research facility ID ORG-001053

Islamabad, 44000, Pakistan

Location

Research facility ID ORG-001070

Karachi, 75050, Pakistan

Location

Research facility ID ORG-001051

Karachi, 75190, Pakistan

Location

Research facility ID ORG-001069

Karachi, 75900, Pakistan

Location

Research facility ID ORG-001050

Karachi, 75950, Pakistan

Location

Research facility ID ORG-001060

Lahore, 54570, Pakistan

Location

Research facility ID ORG-001054

Lahore, 54660, Pakistan

Location

Research facility ID ORG-001055

Lahore, 54660, Pakistan

Location

Research facility ID ORG-001061

Lahore, 54810, Pakistan

Location

Research facility ID ORG-001052

Peshawar, 7041298, Pakistan

Location

MeSH Terms

Conditions

VertigoDizziness

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Officials

  • Raeefuddin Ahmed, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 11, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations