Official Title: “A Multicentre, Double-Blind, Parallel, Randomized, Placebo-Controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Suffering From Allergic Rhinitis (AR)”

Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)

Study Type: Interventional

Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Study Primary Completion Date: September 2005

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine

Primary Measures

• Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment

Secondary Measures

• Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety

Inclusion Criteria:

• At least 2-year history of Allergic Rhinitis that became symptomatic during the annual grass pollen season.
• A skin test for grass pollens positive:
• Have rhinitis symptoms of such severity that the mean T4SS over the baseline period must be 6.

Exclusion Criteria:

• Have an associated asthma requiring corticosteroid treatment,
• Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids,

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Krassimir Mitchev, MD, PhD Study Director UCB  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160589

Study ID Number: A00401

ClinicalTrials.gov Identifier: NCT00160589

Health Authority: France: Afssaps - French Health Products Safety Agency