Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo
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ClinicalTrials.gov Identifier: NCT01890538 |
Recruitment Status :
Completed
First Posted : July 1, 2013
Last Update Posted : May 5, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | June 25, 2013 | |||
First Posted Date ICMJE | July 1, 2013 | |||
Last Update Posted Date | May 5, 2014 | |||
Study Start Date ICMJE | June 2013 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in numeric rating scale [ Time Frame: Change from baseline in numeric rating scale at 30th minute ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
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 | Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo | |||
Official Title ICMJE | Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial | |||
Brief Summary | This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo. The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment |
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Condition ICMJE | Peripheral Vertigo | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
94 | |||
Original Estimated Enrollment ICMJE |
150 | |||
Actual Study Completion Date ICMJE | May 2014 | |||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | Turkey | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01890538 | |||
Other Study ID Numbers ICMJE | KOU KAEK 2013/174 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Nurettin Özgür Doğan, Kocaeli University | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Kocaeli University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Kocaeli University | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |