NCT00521170

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
Last Updated

December 16, 2013

Status Verified

September 1, 2009

Enrollment Period

2 months

First QC Date

August 24, 2007

Last Update Submit

December 13, 2013

Conditions

Allergy

Keywords

LevocetirizineWheal and flareAllergic

Outcome Measures

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

    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

Interventions

LevocetirizineDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Illkirch-Graffenstaden, France

Location

Unknown Facility

Strasbourg, France

Location

MeSH Terms

Conditions

HypersensitivityUrticaria

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Immune System DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, Immediate

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

November 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

December 16, 2013

Record last verified: 2009-09

Locations

FR(2)