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. |
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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 |
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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 |
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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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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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 |
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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 |
Locations[ + expand ][ + ]
Department of Neurology, Emam Hossein Hospital | Tehran, Nezam Abad, Iran, Islamic Republic of, 17666-33815 |
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