Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo
Primary Purpose
Peripheral Vertigo
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Administration of 100 mg dimenhydrinate intravenous
2 g piracetam intravenous
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vertigo focused on measuring vertigo, dimenhydrinate, piracetam
Eligibility Criteria
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
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Piracetam
Dimenhydrinate
Arm Description
2 g intravenous piracetam
Dimenhydrinate 100 mg intravenous
Outcomes
Primary Outcome Measures
Change in numeric rating scale
Secondary Outcome Measures
Full Information
NCT ID
NCT01890538
First Posted
June 25, 2013
Last Updated
May 2, 2014
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT01890538
Brief Title
Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo
Official Title
Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vertigo
Keywords
vertigo, dimenhydrinate, piracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Piracetam
Arm Type
Active Comparator
Arm Description
2 g intravenous piracetam
Arm Title
Dimenhydrinate
Arm Type
Active Comparator
Arm Description
Dimenhydrinate 100 mg intravenous
Intervention Type
Drug
Intervention Name(s)
Administration of 100 mg dimenhydrinate intravenous
Intervention Type
Drug
Intervention Name(s)
2 g piracetam intravenous
Primary Outcome Measure Information:
Title
Change in numeric rating scale
Time Frame
Change from baseline in numeric rating scale at 30th minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurettin Özgür Doğan, M.D., Assistant Professor
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41000
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
15262457
Citation
Scholtz AW, Schwarz M, Baumann W, Kleinfeldt D, Scholtz HJ. Treatment of vertigo due to acute unilateral vestibular loss with a fixed combination of cinnarizine and dimenhydrinate: a double-blind, randomized, parallel-group clinical study. Clin Ther. 2004 Jun;26(6):866-77. doi: 10.1016/s0149-2918(04)90130-0.
Results Reference
background
PubMed Identifier
25052217
Citation
Dogan NO, Avcu N, Yaka E, Yilmaz S, Pekdemir M. Comparison of the therapeutic efficacy of intravenous dimenhydrinate and intravenous piracetam in patients with vertigo: a randomised clinical trial. Emerg Med J. 2015 Jul;32(7):520-4. doi: 10.1136/emermed-2014-204006. Epub 2014 Jul 22.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=11020677
Description
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Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo
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