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Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

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ClinicalTrials.gov Identifier: NCT00520754
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : December 12, 2013
Sponsor:
Information provided by:
UCB Pharma

Tracking Information
First Submitted Date  ICMJE August 24, 2007
First Posted Date  ICMJE August 27, 2007
Last Update Posted Date December 12, 2013
Study Start Date  ICMJE December 2001
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
The efficacy based on daily record cards recordings [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
Safety and pharmacokinetics at 90 days; skin reactivity
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 Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
Official Title  ICMJE The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years.
Brief Summary Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cough
Intervention  ICMJE Drug: levocetirizine dihydrochloride
Study Arms  ICMJE Not Provided
Publications * Cranswick N, Turzíkova J, Fuchs M, Hulhoven R. Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile. Int J Clin Pharmacol Ther. 2005 Apr;43(4):172-7.

*   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: August 24, 2007)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • infants from 2 to 24 months both inclusive
  • suffering from recurrent cough associated with other allergic symptoms
  • hospitalized for respiratory or allergy related problems
  • laboratory results within normal ranges
  • height and weight between percentile 5 and 95

Exclusion Criteria:

  • having taken any of the disallowed medication
  • suffering form any disorder
  • history of sleep apnea
  • having concomitant chronic disease
  • known relevant renal, hepatic, cardiac or metabolism dysfunction
  • known alcohol or drug addiction, severe psychiatric disease for the parent/guardian
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00520754
Other Study ID Numbers  ICMJE A00315
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center UCB Pharma
PRS Account UCB Pharma
Verification Date September 2009

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