Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo

Peripheral Vertigo Clinical Trial

Official title:

Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890538
• Other study ID #: KOU KAEK 2013/174
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2013
• Last updated: May 2, 2014
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Peripheral Vertigo
• Vertigo

Intervention

Drug:
• Administration of 100 mg dimenhydrinate intravenous

• 2 g piracetam intravenous

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in numeric rating scale		Change from baseline in numeric rating scale at 30th minute	No

External Links

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