VertigoVERTIGONCT02213120
To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics.
An observational study of Vertigo, run by Abbott at 11 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo
- How many people
- 400 participants
- Where
- 11 sitesPakistan
- Study dates
- Aug 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic/Private Clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Pakistan11 sites
Research facility ID ORG-001139
Hyderābād, 76090
Research facility ID ORG-001053
Islamabad, 44000
Research facility ID ORG-001070
Karachi, 75050
Research facility ID ORG-001051
Karachi, 75190
Research facility ID ORG-001069
Karachi, 75900
Research facility ID ORG-001050
Karachi, 75950
Research facility ID ORG-001060
Lahore, 54570
Research facility ID ORG-001054
Lahore, 54660
Research facility ID ORG-001055
Lahore, 54660
Research facility ID ORG-001061
Lahore, 54810
Research facility ID ORG-001052
Peshawar, 7041298
About this study
Official title: To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.
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.
- Conditions
- Vertigo
- Keywords
- Vertigo, Dizziness
- Medical subject headings
- Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dizziness | Patients with Dizziness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Quality of Life (QoL) of patients at baselines
Dizziness Handicap Inventory will be used
Measured: 6 months
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.
Measured: 6 months
QoL of patients post treatment
Dizziness Handicap Inventory will be used
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dimension Research
- Responsible party
- Sponsor
- Investigators
- Raeefuddin Ahmed, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213120
- Sponsor's protocol ID
- BETA5003
- Acronym
- VERTIGO
- Status last verified
- May 2015
- First submitted
- 8 Aug 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.
- ClinicalTrials.gov ID
- NCT02213120
- Acronym / sponsor ID
- VERTIGO / BETA5003
- Conditions
- Vertigo
- Keywords
- Vertigo, Dizziness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Dimension Research
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dizziness | – | –Patients with Dizziness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic/Private Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Quality of Life (QoL) of patients at baselines
Time frame: 6 months
Management of vertigo currently in practice
Time frame: 6 months
QoL of patients post treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raeefuddin Ahmed, MD study director
Abbott
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo, run by Abbott at 11 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics (Different Types) of dizziness (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.