NCT Number: NCT00150761
Facial Thermography Study of Levocetirizine Versus Cetirizine
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.
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Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 4
Who can participate
Only the study team can determine whether someone qualifies for participation.
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 immunotherapy
- Skin irritants or UV exposure 48 hours before each visit.
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
UCB Pharma
Industry
Registry information
Official study 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.
Important dates
- Study start
- 2004
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Sep 8, 2005
- Registry last updated
- Aug 26, 2014
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.