Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
BALL
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.
3 other identifiers
interventional
69
1 country
26
Brief Summary
To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2008
Shorter than P25 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
October 14, 2009
CompletedMarch 6, 2015
February 1, 2015
6 months
February 22, 2008
September 9, 2009
February 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
Baseline, 14 days
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
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
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
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
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
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
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
Secondary Outcomes (5)
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
Baseline, 14 days
Study Arms (2)
Placebo
PLACEBO COMPARATORLevocetirizine
EXPERIMENTALInterventions
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (26)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Crescent City, California, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Orange, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
Stockton, California, United States
Unknown Facility
Albany, Georgia, United States
Unknown Facility
Gainesville, Georgia, United States
Unknown Facility
Normal, Illinois, United States
Unknown Facility
Bridgeton, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Barnwell, South Carolina, United States
Unknown Facility
Spartanburg, South Carolina, United States
Unknown Facility
Kingsport, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Sugarland, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Related Publications (1)
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-Aug;31(4):290-5. doi: 10.2500/aap.2010.31.3349.
PMID: 20819318DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2008
First Posted
March 4, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
March 6, 2015
Results First Posted
October 14, 2009
Record last verified: 2015-02