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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
Sponsor:
Information provided by (Responsible Party):
Nurettin Özgür Doğan, Kocaeli University

Tracking Information
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
 (submitted: June 27, 2013)
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 Complete list of historical versions of study NCT01890538 on ClinicalTrials.gov Archive Site
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:

  • Numeric rating scale (1 to 10): Admission
  • Numeric rating scale (1 to 10): After the study drug (No ambulation)*
  • Numeric rating scale (1 to 10): After the study drug (Ambulation)*

    • Ambulation refers to head movements or walking in the room, if applicable.
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
Condition  ICMJE Peripheral Vertigo
Intervention  ICMJE
  • Drug: Administration of 100 mg dimenhydrinate intravenous
  • Drug: 2 g piracetam intravenous
Study Arms  ICMJE
  • Active Comparator: Piracetam
    2 g intravenous piracetam
    Intervention: Drug: 2 g piracetam intravenous
  • Active Comparator: Dimenhydrinate
    Dimenhydrinate 100 mg intravenous
    Intervention: Drug: Administration of 100 mg dimenhydrinate intravenous
Publications *

*   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: May 2, 2014)
94
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
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:

  • Presenting to emergency department with vertigo symptoms
  • Adult patients (over 18)
  • Agree to participate to study (understanding the study protocol and signing the informed consent form)

Exclusion Criteria:

  • Patients under 18 years
  • Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
  • Patient diagnosed with transient ischemic attack
  • Pregnants
  • Patients taking any analgesics or antihistaminic drugs last 24 hours
  • Documented or declared allergy to dimenhydrinate, piracetam or benzodiazepines
  • Patients who do not agree to participate to the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Responsible Party Nurettin Özgür Doğan, Kocaeli University
Study Sponsor  ICMJE Kocaeli University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nurettin Özgür Doğan, M.D., Assistant Professor Kocaeli University
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