Back to resultsPromethazine vs. Lorazepam for Treatment of Vertigo
Primary Purpose
Peripheral Vertigo.
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Promethazine
Lorazepam
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vertigo.
Eligibility Criteria
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
Sites / Locations
- Department of Neurology, Emam Hossein Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Promethazine
lorazepam
Arm Description
IV promethazine (25 mg)
IV lorazepam (2 mg)
Outcomes
Primary Outcome Measures
Mean change in vertigo intensity.
The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications.
Secondary Outcome Measures
Efficacy and Safety outcome measures (nausea change-second dose-adverse events).
Secondary outcomes included, mean change in nausea VAS score, need for second dose of study medications, and the rate of drug-related adverse events for the subjects in each study group after intervention.
Full Information
NCT ID
NCT01827293
First Posted
April 2, 2013
Last Updated
June 13, 2013
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01827293
Brief Title
Promethazine vs. Lorazepam for Treatment of Vertigo
Official Title
Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vertigo.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Promethazine
Arm Type
Active Comparator
Arm Description
IV promethazine (25 mg)
Arm Title
lorazepam
Arm Type
Active Comparator
Arm Description
IV lorazepam (2 mg)
Intervention Type
Drug
Intervention Name(s)
Promethazine
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Primary Outcome Measure Information:
Title
Mean change in vertigo intensity.
Description
The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications.
Time Frame
At 2 hours after intervention.
Secondary Outcome Measure Information:
Title
Efficacy and Safety outcome measures (nausea change-second dose-adverse events).
Description
Secondary outcomes included, mean change in nausea VAS score, need for second dose of study medications, and the rate of drug-related adverse events for the subjects in each study group after intervention.
Time Frame
At 2-8 hours after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Neurology, Emam Hossein Hospital
City
Tehran
State/Province
Nezam Abad
ZIP/Postal Code
17666-33815
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Promethazine vs. Lorazepam for Treatment of Vertigo
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