Peripheral VertigoPhase 4NCT01890538
Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo
A Phase 4 study testing Administration of 100 mg dimenhydrinate intravenous and 2 g piracetam intravenous in people with Peripheral Vertigo, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo. The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vertigo
- What is being tested?
- Administration of 100 mg dimenhydrinate intravenous and 2 g piracetam intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to May 2014
- Phase
- Phase 4
- 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
Who may be able to join
- Presenting to emergency department with vertigo symptoms
- Adult patients (over 18)
- Agree to participate to study (understanding the study protocol and signing the informed consent form)
Who cannot join
- Patients under 18 years
- Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
- Patient diagnosed with transient ischemic attack
- Pregnants
- Patients taking any analgesics or antihistaminic drugs last 24 hours
- Documented or declared allergy to dimenhydrinate, piracetam or benzodiazepines
- Patients who do not agree to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial
This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo.
The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times:
- Numeric rating scale (1 to 10): Admission
- Numeric rating scale (1 to 10): After the study drug (No ambulation)*
- Numeric rating scale (1 to 10): After the study drug (Ambulation)*
- Ambulation refers to head movements or walking in the room, if applicable.
- Conditions
- Peripheral Vertigo
- Being tested
- Administration of 100 mg dimenhydrinate intravenous, 2 g piracetam intravenous
- Keywords
- vertigo, dimenhydrinate, piracetam
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of 100 mg dimenhydrinate intravenousDrug
2 g piracetam intravenousDrug
| Study group | Role | What they receive |
|---|---|---|
| Piracetam | Active comparator | 2 g intravenous piracetam Receives: Drug: 2 g piracetam intravenous |
| Dimenhydrinate | Active comparator | Dimenhydrinate 100 mg intravenous Receives: Drug: Administration of 100 mg dimenhydrinate intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in numeric rating scale
Measured: Change from baseline in numeric rating scale at 30th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurettin Özgür Doğan, Kocaeli University
- Investigators
- Nurettin Özgür Doğan, M.D., Assistant Professor, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890538
- Sponsor's protocol ID
- KOU KAEK 2013/174
- Status last verified
- May 2014
- First submitted
- 25 Jun 2013
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scholtz AW, Schwarz M, Baumann W, Kleinfeldt D, Scholtz HJ. Treatment of vertigo due to acute unilateral vestibular loss with a fixed combination of cinnarizine and dimenhydrinate: a double-blind, randomized, parallel-group clinical study. Clin Ther. 2004 Jun;26(6):866-77. doi: 10.1016/s0149-2918(04)90130-0.
PubMed 15262457Dogan NO, Avcu N, Yaka E, Yilmaz S, Pekdemir M. Comparison of the therapeutic efficacy of intravenous dimenhydrinate and intravenous piracetam in patients with vertigo: a randomised clinical trial. Emerg Med J. 2015 Jul;32(7):520-4. doi: 10.1136/emermed-2014-204006. Epub 2014 Jul 22.
PubMed 25052217
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01890538
- Acronym / sponsor ID
- KOU KAEK 2013/174
- Conditions
- Peripheral Vertigo
- Keywords
- vertigo, dimenhydrinate, piracetam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Jul 2013 (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.
This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo.
The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times:
- Numeric rating scale (1 to 10): Admission
- Numeric rating scale (1 to 10): After the study drug (No ambulation)*
- Numeric rating scale (1 to 10): After the study drug (Ambulation)*
- Ambulation refers to head movements or walking in the room, if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piracetam | Active comparator | Drug: 2 g piracetam intravenous2 g intravenous piracetam |
| Dimenhydrinate | Active comparator | Drug: Administration of 100 mg dimenhydrinate intravenousDimenhydrinate 100 mg intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting to emergency department with vertigo symptoms
- Adult patients (over 18)
- Agree to participate to study (understanding the study protocol and signing the informed consent form)
Key exclusion criteria (7 listed)
- Patients under 18 years
- Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
- Patient diagnosed with transient ischemic attack
- Pregnants
- Patients taking any analgesics or antihistaminic drugs last 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of 100 mg dimenhydrinate intravenous | Drug | Dimenhydrinate |
| 2 g piracetam intravenous | Drug | Piracetam |
Primary outcome
Change in numeric rating scale
Time frame: Change from baseline in numeric rating scale at 30th minute
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 5 May 2014.
- Background: PubMed 15262457Scholtz AW, Schwarz M, Baumann W, Kleinfeldt D, Scholtz HJ. Treatment of vertigo due to acute unilateral vestibular loss with a fixed combination of cinnarizine and dimenhydrinate: a double-blind, randomized, parallel-group clinical study. Clin Ther. 2004 Jun;26(6):866-77. doi: 10.1016/s0149-2918(04)90130-0.
- Derived from this study: PubMed 25052217Dogan NO, Avcu N, Yaka E, Yilmaz S, Pekdemir M. Comparison of the therapeutic efficacy of intravenous dimenhydrinate and intravenous piracetam in patients with vertigo: a randomised clinical trial. Emerg Med J. 2015 Jul;32(7):520-4. doi: 10.1136/emermed-2014-204006. Epub 2014 Jul 22.
- Related InfoLink provided by the sponsor.
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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.
Nurettin Özgür Doğan, M.D., Assistant Professor principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Administration of 100 mg dimenhydrinate intravenous and 2 g piracetam intravenous in people with Peripheral Vertigo, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 7 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 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in numeric rating scale (time frame: Change from baseline in numeric rating scale at 30th minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01890538, which also lists 2 linked publications.
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 5 May 2014.