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

May 2, 2014 updated by: Nurettin Özgür Doğan, Kocaeli University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41000
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Piracetam
2 g intravenous piracetam
Drug: 2 g piracetam intravenous
Active Comparator: Dimenhydrinate
Dimenhydrinate 100 mg intravenous
Drug: Administration of 100 mg dimenhydrinate intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in numeric rating scale
Time Frame: Change from baseline in numeric rating scale at 30th minute
Change from baseline in numeric rating scale at 30th minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Nurettin Özgür Doğan, M.D., Assistant Professor, Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOU KAEK 2013/174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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