Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.

NCT ID: NCT00521170

Last Updated: 2013-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2005-01-31

Brief Summary

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

Conditions

Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Levocetirizine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

Illkirch-Graffenstaden, , France

Strasbourg, , France

Countries

France

Other Identifiers

Eudract Number: 2004-001089-41

Identifier Type: -

Identifier Source: secondary_id

A00373

Identifier Type: -

Identifier Source: org_study_id