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

Purpose

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 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB Pharma:

Primary Outcome Measures:

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 Outcome Measures:

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


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)

Eligibility


Ages Eligible for Study:	2 Years to 6 Years (Child)
Genders Eligible for Study:	Both

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152412

Sponsors and Collaborators

UCB Pharma

Investigators


Study Director:	UCB Clinical Trial Call Center	UCB Pharma

More Information

Additional Information:

Clinical Study Summary on UCB.com This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00152412 History of Changes
Other Study ID Numbers:	A00385
Study First Received:	September 8, 2005
Last Updated:	August 25, 2014
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UCB Pharma:


Allergic Rhinitis, safety, levocetirizine, children Xyzal

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pharmaceutical Solutions	Levocetirizine Cetirizine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2016