Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo

NCT ID: NCT01890538

Last Updated: 2014-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Piracetam

2 g intravenous piracetam

Group Type ACTIVE_COMPARATOR

2 g piracetam intravenous

Intervention Type DRUG

Dimenhydrinate

Dimenhydrinate 100 mg intravenous

Group Type ACTIVE_COMPARATOR

Administration of 100 mg dimenhydrinate intravenous

Intervention Type DRUG

Interventions

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Administration of 100 mg dimenhydrinate intravenous

Intervention Type DRUG

2 g piracetam intravenous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Nurettin Özgür Doğan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurettin Özgür Doğan, M.D., Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 15262457 (View on PubMed)

Dogan 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.

Reference Type DERIVED
PMID: 25052217 (View on PubMed)

Related Links

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Other Identifiers

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KOU KAEK 2013/174

Identifier Type: -

Identifier Source: org_study_id

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