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

This study is currently recruiting participants.
Verified June 2013 by Kocaeli University
Sponsor:
Information provided by (Responsible Party):
Nurettin Özgür Doğan, Kocaeli University
ClinicalTrials.gov Identifier:
NCT01890538
First received: June 25, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention Phase
Peripheral Vertigo
Drug: Administration of 100 mg dimenhydrinate intravenous
Drug: 2 g piracetam intravenous
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Kocaeli University:

Primary Outcome Measures:
  • Change in numeric rating scale [ Time Frame: Change from baseline in numeric rating scale at 30th minute ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Pathological finding in neurologic examination
  • Patients diagnosed with ischemic/hemorrhagic stroke after neuroimaging
  • Patient diagnosed with transient ischemic attack
  • Pregnants
  • Hepatic / renal failure
  • Patients taking any analgesics or antihistaminic drugs last 24 hours
  • Documented or declared allergy to dimenhydrinate or piracetam
  • Patients who do not agree to participate to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890538

Contacts
Contact: Nurettin Özgür Doğan, M.D., Assist. Prof. +905327441644 nurettinozgurdogan@gmail.com

Locations
Turkey
Kocaeli University Recruiting
Kocaeli, Turkey, 41000
Contact: Nurettin Özgür Doğan, M.D., Assistant Professor    +905327441644    nurettinozgurdogan@gmail.com   
Principal Investigator: Nurettin Özgür Doğan, M.D., Assistant Professor         
Sponsors and Collaborators
Kocaeli University
Investigators
Principal Investigator: Nurettin Özgür Doğan, M.D., Assistant Professor Kocaeli University
  More Information

Additional Information:
Publications:
Responsible Party: Nurettin Özgür Doğan, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT01890538     History of Changes
Other Study ID Numbers: KOU KAEK 2013/174
Study First Received: June 25, 2013
Last Updated: June 27, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Kocaeli University:
vertigo
dimenhydrinate
piracetam

Additional relevant MeSH terms:
Vestibular Diseases
Vertigo
Dizziness
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders
Dimenhydrinate
Piracetam
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Nootropic Agents

ClinicalTrials.gov processed this record on April 16, 2014