Facial Thermography Study of Levocetirizine Versus Cetirizine

NCT ID: NCT00150761

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2004-10-31

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 IR thermography.

Conditions

Anti-allergic Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Interventions

Levocetirizine (drug)

Intervention Type: DRUG

Eligibility 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 immunotherapy
• Skin irritants or UV exposure 48 hours before each visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

Other Identifiers

A00380

Identifier Type: -

Identifier Source: org_study_id