Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis

Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152412
• Other study ID #: A00385
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: August 25, 2014
• Start date: June 2004
• Est. completion date: December 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each of the 4 individual rhinitis symptom scores

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• • 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Levocetirizine oral solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	To describe the serum concentration of levocetirizine after 1,3 and 6 hours following the last treatment intake

External Links

•   Clinical Study Summary on UCB.com