Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00521131
First received: August 24, 2007
Last updated: December 13, 2013
Last verified: September 2009

August 24, 2007
December 13, 2013
September 2002
May 2003   (final data collection date for primary outcome measure)
Number of comfortable days, as assessed by the subject [ Time Frame: 30 days ]
Number of confortable days, as assessed by the subject [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00521131 on ClinicalTrials.gov Archive Site
Sum of 4 and 5 rhinitis symptoms and safety [ Time Frame: Week 1 and over 30 days ]
Sum of 4 and 5 rhinitis symptoms and safety [ Time Frame: Week/and over 30 days ]
Not Provided
Not Provided
 
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
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

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Rhinitis
  • Allergic
  • Perennial
Drug: Levocetirizine dihydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
453
May 2003
May 2003   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00521131
A00333
No
Not Provided
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center UCB, Inc.
UCB, Inc.
September 2009

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