Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00521170
• Date of registration: 24/08/2007
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.
• Scientific 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.
• Date of first enrolment: November 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00521170
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: UCB Pharma

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Allergy

Intervention(s)

Drug: Levocetirizine

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

A00373

Eudract Number: 2004-001089-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors