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: September 9, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 24, 2007

Last Updated Date

September 9, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of confortable days, as assessed by the subject [ Time Frame: 30 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00521131 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sum of 4 and 5 rhinitis symptoms and safety [ Time Frame: Week 1 and over 30 days ]

Original Secondary Outcome Measures ^ICMJE

Sum of 4 and 5 rhinitis symptoms and safety [ Time Frame: Week/and over 30 days ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Rhinitis
Allergic
Perennial

Intervention ^ICMJE

Drug: Levocetirizine dihydrochloride

Study Arm (s)

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

Enrollment ^ICMJE

453

Completion Date

May 2003

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00521131

Other Study ID Numbers ^ICMJE

A00333

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

Information Provided By

UCB, Inc.

Verification Date

September 2009

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

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