Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00521170
First received: August 24, 2007
Last updated: December 13, 2013
Last verified: September 2009

August 24, 2007
December 13, 2013
November 2004
January 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00521170 on ClinicalTrials.gov Archive Site
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
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
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Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.
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.

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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Allergy
Drug: Levocetirizine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
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Contact information is only displayed when the study is recruiting subjects
France
 
NCT00521170
A00373, Eudract Number: 2004-001089-41
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UCB Pharma
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Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP