Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00521170
First received: August 24, 2007
Last updated: September 9, 2009
Last verified: September 2009
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Purpose
Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergy |
Drug: Levocetirizine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official 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. |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- 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 Measures:
- 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
| Study Start Date: | November 2004 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
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
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00521170 History of Changes |
| Other Study ID Numbers: | A00373, Eudract Number: 2004-001089-41 |
| Study First Received: | August 24, 2007 |
| Last Updated: | September 9, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by UCB, Inc.:
|
Levocetirizine Wheal and flare Allergic |
Additional relevant MeSH terms:
|
Levocetirizine Cetirizine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Allergic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013