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

Allergic Rhinitis Clinical Trial

— PAL  

Official title:

A Multi-Center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619801
• Other study ID #: A00426
• Secondary ID: RPCE07K24042015-
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2008
• Last updated: February 18, 2015
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: February 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Chronic Urticaria
• Rhinitis
• Urticaria

Intervention

Drug:
• Levocetirizine
Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
• Placebo
Placebo oral drops (5 drops) dosed twice a day for 2 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)		Baseline, 14 days	No
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval	The RR interval refers to the respective time interval in the Electrocardiogram (ECG).	Baseline, 14 days	No
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval	The PR interval refers to the respective time interval in the Electrocardiogram (ECG).	Baseline, 14 days	No
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration	The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).	Baseline, 14 days	No
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).	Baseline, 14 days	No
Primary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).	Baseline, 14 days	No
Primary	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).	7 days	No
Primary	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)	The QT interval refers to the respective time interval in the Electrocardiogram (ECG).	14 days	No
Secondary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin		Baseline, 14 days	No
Secondary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)		Baseline, 14 days	No
Secondary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)		Baseline, 14 days	No
Secondary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen		Baseline, 14 days	No
Secondary	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine		Baseline, 14 days	No

External Links

•   FDA Safety Alerts and Recalls
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