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OpenTrials
Completed

NCT Number: NCT00521170

Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.

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

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Illkirch-Graffenstaden, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levocetirizine

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Aug 27, 2007
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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