Facial Thermography Study of Levocetirizine Versus Cetirizine
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00150761
First received: September 6, 2005
Last updated: September 9, 2009
Last verified: September 2009
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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:
Drug Information available for:
Histamine
Histamine phosphate
Histamine dihydrochloride
Cetirizine
Cetirizine hydrochloride
Levocetirizine
Levocetirizine dihydrochloride
U.S. FDA Resources
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 immunotheray
- Skin irritants or UV exposure 48 hours before each visit.
Contacts and Locations More 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: | September 9, 2009 |
| 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 June 17, 2013