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Effect of V0251 in Acute Vertigo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01583738
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Tracking Information
First Submitted Date  ICMJE April 11, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date October 30, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
"Vertigo Symptoms Score" (VSS) rated by patient using VAS [ Time Frame: 30 min ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01583738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • "Concomitant and Vegetative Symptoms Score" (CVSS) rated by patients using VAS [ Time Frame: 30 min, 2 hours and 4 hours post dose ]
  • Number of patients with Adverse Events as a measure of safety and tolerability [ Time Frame: 30 min, 2 hours and 4 hours post dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of V0251 in Acute Vertigo
Official Title  ICMJE Not Provided
Brief Summary Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Vertigo
Intervention  ICMJE
  • Drug: V0251
    single dose
  • Drug: placebo
    single dose
Study Arms  ICMJE
  • Experimental: V0251
    Intervention: Drug: V0251
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2012)
132
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women
  • Age 18 to 70 years
  • Acute vertigo attack due to vestibular disorder

Exclusion Criteria:

  • Signs of brain, brainstem and/or cerebellar dysfunction
  • Concomitant central neurological disorder
  • Psychogenic vertigo
  • Use of ototoxic drugs causing vertigo or dizziness within the last month
  • Use of anti-dizziness medications from the onset of symptoms, except if the dosage had been stable for at least 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   France,   Germany,   Hungary,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583738
Other Study ID Numbers  ICMJE V0251 IV 202 4A
2011-003412-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierre Fabre Medicament
Study Sponsor  ICMJE Pierre Fabre Medicament
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pierre Fabre Medicament
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP