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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

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo: A Double Blind Randomized Clinical Trial
Study Start Date : June 2013
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in numeric rating scale [ Time Frame: Change from baseline in numeric rating scale at 30th minute ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890538


Locations
Turkey
Kocaeli University
Kocaeli, Turkey, 41000
Sponsors and Collaborators
Kocaeli University
Investigators
Principal Investigator: Nurettin Özgür Doğan, M.D., Assistant Professor Kocaeli University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nurettin Özgür Doğan, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT01890538     History of Changes
Other Study ID Numbers: KOU KAEK 2013/174
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014

Keywords provided by Nurettin Özgür Doğan, Kocaeli University:
vertigo
dimenhydrinate
piracetam

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