Promethazine vs. Lorazepam for Treatment of Vertigo | RxWiki

Promethazine vs. Lorazepam for Treatment of Vertigo

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Peripheral Vertigo.
Intervention	Drug: Promethazine Drug: Lorazepam
Phase	Phase 3
Sponsor	Shahid Beheshti Medical University
Responsible Party	Shahid Beheshti Medical University
ClinicalTrials.gov Identifier	NCT01827293
First Received	April 2, 2013
Last Updated	June 13, 2013
Last verified	June 2013

Tracking Information[ + expand ][ + ]

First Received Date	April 2, 2013
Last Updated Date	June 13, 2013
Start Date	April 2013
Estimated Primary Completion Date	June 2013
Current Primary Outcome Measures	Mean change in vertigo intensity. [Time Frame: At 2 hours after intervention.] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Efficacy and Safety outcome measures (nausea change-second dose-adverse events). [Time Frame: At 2-8 hours after intervention.] [Designated as safety issue: Yes]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.

Descriptive Information[ + expand ][ + ]

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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Peripheral Vertigo.
Intervention	Drug: Promethazine Drug: Lorazepam
Study Arm (s)	Active Comparator: Promethazine IV promethazine (25 mg) Active Comparator: lorazepam IV lorazepam (2 mg)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	210
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Iran, Islamic Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01827293
Other Study ID Numbers	SB-067
Has Data Monitoring Committee	Yes
Information Provided By	Shahid Beheshti Medical University
Study Sponsor	Shahid Beheshti Medical University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	June 2013

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