Facial Thermography Study of Levocetirizine Versus Cetirizine

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00150761
First received: September 6, 2005
Last updated: December 13, 2013
Last verified: September 2009
  Purpose

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 Intervention Phase
Anti-allergic Agents
Drug: Levocetirizine (drug)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 60
Study Start Date: July 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150761

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00150761     History of Changes
Other Study ID Numbers: A00380, EudraCT 2004-000295-13
Study First Received: September 6, 2005
Last Updated: December 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on April 14, 2014