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

NCT01890538 | Completed Phase 4 DMC

• 1 other identifier: KOU KAEK 2013/174
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vertigo

Keywords

vertigo; dimenhydrinate; piracetam

Outcome Measures

Primary Outcomes (1)

• Change in numeric rating scale

  Change from baseline in numeric rating scale at 30th minute

Study Arms (2)

Piracetam

ACTIVE COMPARATOR

2 g intravenous piracetam

Drug: 2 g piracetam intravenous

Dimenhydrinate

ACTIVE COMPARATOR

Dimenhydrinate 100 mg intravenous

Drug: Administration of 100 mg dimenhydrinate intravenous

Interventions

Administration of 100 mg dimenhydrinate intravenous DRUG

Dimenhydrinate

2 g piracetam intravenous DRUG

Piracetam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 15262457 BACKGROUND

• 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.

  PMID: 25052217 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nurettin Özgür Doğan, M.D., Assistant Professor

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 1, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 5, 2014

Record last verified: 2014-05

Locations

TU (1)