Safety Study of Levocetirizine and Fexofenadine
Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Levocetirizine (Drug); Fexofenadine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s): Marcus Maurer, MD, Principal Investigator, Affiliation: Charite Universitätsmedizin Berlin
Summary
Primary objective:
The comparative efficacy of levocetirizine 5 mg once daily with that of fexofenadine 60 mg
twice daily against histamine induced wheal, flare and itch responses measured at 0
(baseline), 0. 5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours.
Secondary objectives:
1. The areas under the curves (0 , 12 hours, 12 - 24 hours and 0 - 24 hours) for
inhibition of histamine induced wheal, flare and itch responses for levocetirizine 5 mg
once daily and fexofenadine 60 mg twice daily.
2. The number of individuals with peak responses in each 10 percentile (Because of the
variable absorption of fexofenadine, it is predicted that fexofenadine will have a
variable response between individuals).
3. The mean plasma levels of levocetirizine and fexofenadine at 0 (baseline), 0. 5, 1, 2,
3, 4, 6, 8, 10, 12 and 24 hours.
Clinical Details
Official title: Comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg Once Daily With Fexofenadine 60 mg Twice Daily in the Histamine Induced Wheal, Flare and Itch Response
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal- and flare and itch response
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese
origin, will be recruited for this study
Exclusion Criteria:
- None of the subjects will have taken oral antihistamines, antidepressants,
antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids
or mast cell stabilizers to the skin for 2 weeks prior to testing.
- No subject shall perform physical exercise for 4 hours prior to the skin prick
testing.
- Especially, Bronchial asthma, anaphylactic reactions in the history, use of
beta-blockers, skin diseases in the test field are exclusion criteria.
Locations and Contacts
University of Berlin Charité, Berlin 10117, Germany
Additional Information
Starting date: February 2011
Last updated: April 24, 2012
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