Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months

Allergic Rhinitis Clinical Trial

— BALL  

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628108
• Other study ID #: A00423
• Secondary ID: RPCE08K24032007-
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2008
• Last updated: February 18, 2015
• Start date: March 2008
• Est. completion date: September 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

To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 11 Months

Eligibility

Inclusion Criteria:

• Outpatient, male or female pediatric subject, aged from 6 to 11 months (6 months - < 1 year) at the randomization visit

• The subject must present at least one symptom most commonly associated with allergic rhinitis or chronic idiopathic urticaria

• Candidate for antihistamine treatment or received antihistamine in the past for similar symptoms as those presenting

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 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 (including exposure through breast milk) of the following medications within the specified wash-out period before the Randomization Visit (V2):

• Systemic corticosteroids within the past 28 days

• Leukotriene-receptor antagonists (e.g. montelukast [Singulair] or zafirlukast [Accolate] within the past 7 days)

• Mast-cell stabilizers (e.g. cromolyn or nedocromil) within the past 7 days

• 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

• Systemic antibiotics within the past 7 days

• 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

• Sibling with sleep apnea or sudden infant death syndrome (SIDS)

• Exposure to other conditions known to be potential risk factors for SIDS, such as but not limited to (this should be determined on a case by case basis taking into account the subject's entire medical history and environmental living conditions):

• Mothers who smoked or abused drugs during pregnancy

• Extremely young mothers (defined as age 19 or younger when pregnant)

• Children currently exposed to a caregiver which is a heavy cigarette smoker (defined as smoking at least a pack of cigarettes per day)

• Babies who sleep regularly on their face or are not put to sleep on their backs

• Premature birth gestational age = 37 weeks) or low birth weight (below 10 percentile for gestational age)

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 1.25 mg
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks

Other:
• Placebo
Placebo oral liquid once a day for two 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 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	The QT interval refers to the respective time 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 Aminontransferase (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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