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Sponsored by: |
UCB |
Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00152412 |
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 treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each of the 4 individual rhinitis symptom scores
Condition | Intervention | Phase |
Allergic Rhinitis |
Drug: Levocetirizine oral solution |
Phase II |
ChemIDplus related topics: | Levocetirizine dihydrochloride Levocetirizine |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A 4 Week Open, Multi-Center Study Evaluating the Safety of Levocetirizine 1.25 mg b.i.d. Given as 0.5 mg/mL Oral Solution in 2 to 6 Year-Old Children Suffering From Allergic Rhinitis. |
Estimated Enrollment: | 30 |
Study Start Date: | June 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 2 Years to 6 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
At Visit 1:
At Visit 2:
Exclusion Criteria:
• Presence of asthma requiring treatment by inhaled corticosteroids.
Study ID Numbers: | A00385, EudraCT number: 2004-000180-96 |
First Received: | September 8, 2005 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00152412 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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