Promethazine vs. Lorazepam for Treatment of Vertigo

NCT ID: NCT01827293

Last Updated: 2013-06-14

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

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-06-30

Brief Summary

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This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Promethazine

IV promethazine (25 mg)

Group Type ACTIVE_COMPARATOR

Promethazine

Intervention Type DRUG

Lorazepam

Intervention Type DRUG

lorazepam

IV lorazepam (2 mg)

Group Type ACTIVE_COMPARATOR

Promethazine

Intervention Type DRUG

Lorazepam

Intervention Type DRUG

Interventions

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Promethazine

Intervention Type DRUG

Lorazepam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older
* Background history of positional vertigo

Exclusion Criteria

* Unable to provide informed consent
* Pregnant or possibly pregnant
* Known allergy to study medications
* Use of antiemetic agents in the previous 24 hours
* Evidence of drug-induced vertigo or orthostatic hypotension
* Central pathologies/central origin for vertigo
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shadi Asadollahi

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurology, Emam Hossein Hospital

Tehran, Nezam Abad, Iran

Site Status

Countries

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Iran

Other Identifiers

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SB-067

Identifier Type: -

Identifier Source: org_study_id

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