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 - Full Text View

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00619801

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis Chronic Urticaria	Drug: Levocetirizine Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hives

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
The RR interval refers to the respective time interval in the Electrocardiogram (ECG).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
The PR interval refers to the respective time interval in the Electrocardiogram (ECG).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
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) [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
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) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

Secondary Outcome Measures:

Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine [ Time Frame: Baseline, 14 days ] [ Designated as safety issue: No ]

Enrollment:	173
Study Start Date:	March 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
Experimental: Levocetirizine	Drug: Levocetirizine Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks Other Name: Xyzal

Eligibility

Ages Eligible for Study:	2 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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.
Caregivers(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 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):
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619801

Show 28 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Product Information This link exits the ClinicalTrials.gov site

No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hampel F, Ratner P, Haeusler JM. Safety and tolerability of levocetirizine dihydrochloride in infants and children with allergic rhinitis or chronic urticaria. Allergy Asthma Proc. 2010 Jul;31(4):290-5.

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00619801 History of Changes
Other Study ID Numbers:	A00426, RPCE07K2404
Study First Received:	February 11, 2008
Results First Received:	July 28, 2009
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Xyzal
Levocetirizine
Allergy
Children
Seasonal Allergies

Additional relevant MeSH terms:

Rhinitis
Urticaria
Stress, Psychological
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Behavioral Symptoms

Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012