Status:
COMPLETED
Facial Thermography Study of Levocetirizine Versus Cetirizine
Lead Sponsor:
UCB Pharma
Conditions:
Anti-allergic Agents
Eligibility:
MALE
18-55 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00150761
Start Date
July 1 2004
End Date
October 1 2004
Last Update
August 26 2014
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