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Trial record 1 of 1 for:    NCT00521131
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Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

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ClinicalTrials.gov Identifier: NCT00521131
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : December 16, 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 16, 2013
Study Start Date  ICMJE September 2002
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
Number of comfortable days, as assessed by the subject [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
Number of confortable days, as assessed by the subject [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2007)
Sum of 4 and 5 rhinitis symptoms and safety [ Time Frame: Week 1 and over 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
Sum of 4 and 5 rhinitis symptoms and safety [ Time Frame: Week/and over 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Official Title  ICMJE Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites
Brief Summary Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Rhinitis
  • Allergic
  • Perennial
Intervention  ICMJE Drug: Levocetirizine dihydrochloride
Study Arms  ICMJE Not Provided
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: August 24, 2007)
453
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2003
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female ≥ 12 years
  • suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
  • positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
  • the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5

Exclusion Criteria:

  • seasonal allergic rhinitis likely to change significantly the symptoms of the subject
  • an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
  • asthma requiring corticosteroid treatment
  • atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
  • associated ENT disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00521131
Other Study ID Numbers  ICMJE A00333
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