Status:
COMPLETED
Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis
Lead Sponsor:
UCB Pharma
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
2-6 years
Phase:
PHASE2
Brief Summary
4 week open study to evaluate the safety of levocetirizine in young children (2 - 6 years) suffering from allergic rhinitis. As secondary objective, this study will assess the efficacy of the treatmen...
Eligibility Criteria
Inclusion
- At Visit 1:
- Male or female outpatients aged 2 to 6 years old.
- Subjects suffering from allergic rhinitis (perennial and/or seasonal) and symptomatic as attested by the Daily Record Card (DRC).
- At Visit 2:
- Respected wash-out periods for the forbidden medication.
Exclusion
- • Presence of asthma requiring treatment by inhaled corticosteroids.
- Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids, or any other disease requiring the administration of oral or topical corticosteroids, immunomodulatory drugs, anti-inflammatory, or cytotoxic drugs.
- Use during the course of the study, or during the specific wash-out periods, of any of the following medications: intranasal or systemic corticosteroids (within 7 days), ketotifen (within 7 days), nedocromil or cromoglicate (within 7 days), loratadine and desloratadine (within 7 days), other antihistamines (within 3 days) or decongestants (per os, nasal spray, or drops - within 3 days), or any other concomitant medications that, in the opinion of the Investigator, interfered with the study.
- Initiation or change of dose of an immunotherapy regimen during the course of the study.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00152412
Start Date
June 1 2004
End Date
December 1 2004
Last Update
August 26 2014
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