Official Title: “Randomized, Monocenter, Double Blind, Placebo-Controlled, Single Oral Dose, Three-Way Cross Over Study, to Compare Levocetirizine and Desloratadine on Allergen-Induced Wheal and Flare Reaction During 24 Hours in 18 Adult Allergic Volunteers.”

Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine

Primary Measures

• Compare the activity of levocetirizine and desloratadine on allergen-induced wheal and flare reaction. Response to allergen administered by skin prick test (SPT) measured by the wheal and flare surface areas
  • Time Frame: 15 minutes
    

Secondary Measures

• Compare the AUC from pre-dose to 24 hours post-dose between levocetirizine and placebo and between desloratadine and placebo obtained for wheal and for flare areas. Compare the AUC from pre-dose to 12 hours post-dose

Inclusion Criteria:

• Male and female allergic volunteers: Diagnosed allergy based on medical history and on positivity to skin tests to at least one of the standardized allergen including grass pollens, tree pollens, house dust mites, cat and dog dander and with a positive RAST for the specific selected allergen ≥ class 2

Exclusion Criteria:

• Pregnancy or lactating females, or females with childbearing potential without reliable contraception
• History or presence of any chronic or acute illness or disorder capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the trial medication
• Heavy caffeine drinker (> 5 cups of coffee, tea, cola, etc … per day)
• Any drug treatment, including prescribed or non-prescription medicines (except hormonal contraceptives or post-menopausal hormonal replacement therapy for females and occasional use of paracetamol not exceeding 2 g/day with a maximum dose of 10 g per 14 days), taken from 14 days before study drug administration; the wash-out period after intake of systemic corticosteroids is at least 4 weeks
• Known allergy/intolerance to the study drug or any medicine chemically related to study drug or its excipients (lactose, cellulose...)
• Participation in another clinical trial, blood donation or significant blood loss (>
• 450 mL) less than 12 weeks before the study drug administration
• Skin irritant or 48 hours UV exposure before each visit
• Immunotherapy received during the current year
• Any clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable for the trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Isabelle Campine Study Director UCB Pharma SA  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00521170

Study ID Number: A00373

ClinicalTrials.gov Identifier: NCT00521170

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