Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-01-31

Brief Summary

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

Detailed Description

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Conditions

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Allergy

Keywords

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Levocetirizine Wheal and flare Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levocetirizine

Intervention Type DRUG

Eligibility Criteria

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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

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Illkirch-Graffenstaden, , France

Site Status

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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Eudract Number: 2004-001089-41

Identifier Type: -

Identifier Source: secondary_id

A00373