Facial Thermography Study of Levocetirizine Versus Cetirizine - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00150761

Purpose

Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of IR thermography.

Condition	Intervention	Phase
Anti-allergic Agents	Drug: Levocetirizine (drug)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind
Official Title:	A Randomized, Double-blind, Double Dummy, Placebo Controlled, Cross-over Exploratory Trial in Healthy Male Adult Subjects: Comparison by Means of Infrared Thermography of the Anti-H1 Potency of Levocetirizine 5 mg and Cetirizine 10 mg Tablet Single Oral Dose After Nasal Histamine Provocation.

Resource links provided by NLM:

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride Cetirizine Cetirizine hydrochloride Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

To compare by means of infrared (IR) thermography the anti-histaminic potency of levocetirizine 5mg (single dose) and cetirizine 5mg (single dose) using a placebo as control following 2 nasal histamine provocations (NHP) performed respectively 10 minutes

Secondary Outcome Measures:

To assess and compare onset of action of levocetirizine 5 mg and cetirizine 10 mg
To explore predictive value of screening thermography parameters on treatment effect
To collect additional safety information on levocetizine

Estimated Enrollment:	60
Study Start Date:	July 2004
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male

Criteria

Inclusion Criteria:

Healthy male Caucasian subject aged between 18 and 55 years (both inclusive).
Subject must have a positive prick test to histamine (wheal diameter ≥ 6 mm with histamine dihydrochloride (100 mg/mL) and ≤ 3 mm with diluent control).

Exclusion Criteria:

History of allergic disease, documented or suspected, including but not limited to: asthma, whether or not considered as allergic; nocturnal cough episode suspected to be of asthma-equivalent nature (three or more consecutive nights resulting in sleep disturbances) ; allergic rhinitis, conjunctivitis or sinusitis; nasal polyposis; dermatitis of the face or neck; drug or food allergy.
Any clinically significant vascular disease such as hyper- or hypotension, venous disorder, vasculitis etc.
History of hot flushes and any other vasomotor disorders.
ENT infection or Upper Respiratory Tract Infection not completely cured at least one week before inclusion.
Any known history of laryngeal edema.
Nasal structural abnormalities (e.g. deviation of the nasal septum…).
Recent immunotheray
Skin irritants or UV exposure 48 hours before each visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150761

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00150761 History of Changes
Other Study ID Numbers:	A00380, EudraCT 2004-000295-13
Study First Received:	September 6, 2005
Last Updated:	September 9, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:

Nasal histamine provocation, facial thermography, levocetirizine, cetirizine,
Xyzal, Zyrtec

Additional relevant MeSH terms:

Cetirizine
Levocetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating

Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012