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Facial Thermography Study of Levocetirizine Versus Cetirizine

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ClinicalTrials.gov Identifier: NCT00150761
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : August 26, 2014
Sponsor:
Information provided by:
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anti-allergic Agents Drug: Levocetirizine (drug) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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.
Study Start Date : July 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To assess and compare onset of action of levocetirizine 5 mg and cetirizine 10 mg
  2. To explore predictive value of screening thermography parameters on treatment effect
  3. To collect additional safety information on levocetizine

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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 immunotherapy
  • Skin irritants or UV exposure 48 hours before each visit.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150761


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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Additional Information:
Clinical Study Summary on UCB.com  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00150761     History of Changes
Other Study ID Numbers: A00380
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: September 2009

Keywords provided by UCB Pharma:
Nasal histamine provocation, facial thermography, levocetirizine, cetirizine,
Xyzal, Zyrtec

Additional relevant MeSH terms:
Histamine
Cetirizine
Levocetirizine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists