Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis
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ClinicalTrials.gov Identifier: NCT00152412 |
Recruitment Status :
Completed
First Posted : September 9, 2005
Last Update Posted : August 26, 2014
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Condition or disease | Intervention/treatment | Phase |
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Allergic Rhinitis | Drug: Levocetirizine oral solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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. |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | December 2004 |
Actual Study Completion Date : | December 2004 |
- To assess safety of levocetirizine 1.25 mg bid given as 0.5 mg/mL oral solution in 2 to 6 years old children suffering from allergic rhinitis over 4 weeks of treatment
- To assess efficacy of 1.25 mg levocetirizine 0.5 mg/mL oral solution bid in 2 to 6 years old children suffering from allergic rhinitis over 4 weeks by means of the T4SS and each of the 4 individual rhinitis
- To describe the serum concentration of levocetirizine after 1,3 and 6 hours following the last treatment intake

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Ages Eligible for Study: | 2 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
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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).
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At Visit 2:
- Respected wash-out periods for the forbidden medication.
Exclusion Criteria:
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• 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152412
Study Director: | UCB Clinical Trial Call Center | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00152412 |
Other Study ID Numbers: |
A00385 |
First Posted: | September 9, 2005 Key Record Dates |
Last Update Posted: | August 26, 2014 |
Last Verified: | September 2009 |
Allergic Rhinitis, safety, levocetirizine, children Xyzal |
Rhinitis Rhinitis, Allergic Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Levocetirizine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |