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Clinical Trials/NCT00150761
NCT00150761CompletedPhase 4

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.

UCB Pharma0 sites60 target enrollmentStarted: July 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
UCB Pharma
Enrollment
60
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
Double

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Outcomes

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

Investigators

Sponsor
UCB Pharma
Sponsor Class
Industry

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