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Promethazine vs. Lorazepam for Treatment of Vertigo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827293
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : June 14, 2013
Sponsor:
Information provided by (Responsible Party):
Shadi Asadollahi, Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE April 2, 2013
First Posted Date  ICMJE April 9, 2013
Last Update Posted Date June 14, 2013
Study Start Date  ICMJE April 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2013)
Mean change in vertigo intensity. [ Time Frame: At 2 hours after intervention. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
Mean change in vertigo intensity. [ Time Frame: At 30 minutes, 4 hours, 6 hours after intervention. ]
The primary efficacy outcome was the mean change in the vertigo intensity score between pre- post-intervention at 30 minutes, 4 hours, 6 hours after administration of study medications and the percentage of patients in each group who were vertigo free to go home after 6 hours, without further Emergency Department intervention (based on the difference between the pre-maneuver intervention score during the Hallpike test).
Change History Complete list of historical versions of study NCT01827293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2013)
Efficacy and Safety outcome measures (nausea change-second dose-adverse events). [ Time Frame: At 2-8 hours after intervention. ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promethazine vs. Lorazepam for Treatment of Vertigo
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vertigo.
Intervention  ICMJE
  • Drug: Promethazine
  • Drug: Lorazepam
Study Arms  ICMJE
  • Active Comparator: Promethazine
    IV promethazine (25 mg)
    Interventions:
    • Drug: Promethazine
    • Drug: Lorazepam
  • Active Comparator: lorazepam
    IV lorazepam (2 mg)
    Interventions:
    • Drug: Promethazine
    • Drug: Lorazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2013)
210
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2013)
90
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01827293
Other Study ID Numbers  ICMJE SB-067
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shadi Asadollahi, Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP