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

• ClinicalTrials.gov Identifier: NCT01890538
• Recruitment Status: Completed
• First Posted: July 1, 2013
• Last Update Posted: May 5, 2014
• Sponsor: Kocaeli University
• Information provided by (Responsible Party): Nurettin Özgür Doğan, Kocaeli University

Tracking Information

• First Submitted Date: June 25, 2013
• First Posted Date: July 1, 2013
• Last Update Posted Date: May 5, 2014
• Study Start Date: June 2013
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 27, 2013): Change in numeric rating scale [ Time Frame: Change from baseline in numeric rating scale at 30th minute ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01890538 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Peripheral Vertigo

Intervention

• Drug: Administration of 100 mg dimenhydrinate intravenous
• Drug: 2 g piracetam intravenous

Study Arms

• Active Comparator: Piracetam
  2 g intravenous piracetam
  Intervention: Drug: 2 g piracetam intravenous
• Active Comparator: Dimenhydrinate
  Dimenhydrinate 100 mg intravenous
  Intervention: Drug: Administration of 100 mg dimenhydrinate intravenous

Publications *

• 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.
• Doğan NÖ, Avcu N, Yaka E, Yılmaz 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 2, 2014): 94
• Original Estimated Enrollment (submitted: June 27, 2013): 150
• Actual Study Completion Date: May 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT01890538
• Other Study ID Numbers: KOU KAEK 2013/174
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nurettin Özgür Doğan, Kocaeli University
• Study Sponsor: Kocaeli University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Kocaeli University
• Verification Date: May 2014