Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin (PAL)

UCB

Status and phase

Completed

Phase 3

Conditions

Chronic Urticaria

Allergic Rhinitis

Treatments

Drug: Levocetirizine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00619801

RPCE07K2404

A00426

2015-000205-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.

Enrollment

173 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatient, male or female pediatric subject, ages 1 to less than 6 years old at the Randomization Visit (V2) (1 - < 6 years old)
The subject must present at least one of the following symptoms, most commonly associated with allergic rhinitis or chronic urticaria: nasal itching, sneezing, rhinorrhea, nasal congestion, tearing, eye redness and itching of eyes, ears and/or palate, skin wheals and itching of the skin
Subjects (age 2 to less than 6 years only) suffering from allergic rhinitis (AR) should have a documented allergy measured by positive skin prick test or RAST (Radioallergosorbent Test) performed within the last 6 months prior to randomization
Candidate for antihistamine treatment or received antihistamine in the past for similar symptoms as those presenting
Caregiver(s) have been informed of the nature and aims of the study and have given their written informed consent for the subject to participate in this study
Caregiver(s) able to understand information given, the text of the informed consent, and be able to complete the daily record card (DRC)

Exclusion criteria

Any clinically significant medical condition or abnormality other than the primary diagnosis for which an antihistamine is indicated
Be initiating or changing the dose of an immunotherapy regimen during the course of the study (Visit 1 to Visit 4)
Any electrocardiogram (ECG) parameters, including a QTcF interval > 443 msec measured by an ECG obtained at the Screening Visit, outside the normal reference ranges
Any clinical laboratory tests performed at the Screening Visit, other than those related with the allergic condition, outside the reference ranges. Subjects having values outside the accepted reference range can be included if in the Investigator's opinion, they are of no clinical significance
Personal history of seizure, febrile seizure or sleep apnea
Below the lower 5th or above 95th percentile for body weight and/or height based upon CDC Growth Charts for Body Weight and Length
Allergy or intolerance to levocetirizine dihydrochloride or its excipients, or to any other piperazine derivatives, such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine
Current or past intake of the following medications (including exposure through breast milk) within the specified wash-out period before the Randomization Visit (V2):
1. Systemic corticosteroids within the past 28 days
2. Leukotriene-receptor antagonists (e.g. montelukast [Singulair] or zafirlukast [Accolate] within the past 7 days)
3. Mast-cell stabilizers (e.g. cromolyn or nedocromil) within the past 7 days
4. Other antihistamines or cough and cold preparations (with the exception of single ingredient guaifenesin products) or over-the-counter (OTC) sleep aid medications within the past 7 days
5. Systemic antibiotics within the past 7 days
6. Other concomitant medications that will interfere with the study, in the opinion of the investigator
Previous participation in another clinical/pharmacological trial within the past month prior to V1
Have already participated in this study or participated in this study at another site
Children of any member of the study site staff