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
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
3 other identifiers
interventional
173
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2008
Shorter than P25 for phase_3
28 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 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
September 4, 2009
CompletedMarch 6, 2015
February 1, 2015
4 months
February 11, 2008
July 28, 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 duration 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 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 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 Aminotransferase (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 oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
Eligibility Criteria
You may qualify if:
- 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)
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 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 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (28)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Crescent City, California, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Wildomar, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Pueblo, Colorado, United States
Unknown Facility
Savannah, Georgia, United States
Unknown Facility
Stockbridge, Georgia, United States
Unknown Facility
Normal, Illinois, United States
Unknown Facility
Overlook Park, Kansas, United States
Unknown Facility
Owensboro, Kentucky, United States
Unknown Facility
Metarie, Louisiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Papillon, Nebraska, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Barnwell, South Carolina, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
New Braunfels, 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 11, 2008
First Posted
February 21, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
March 6, 2015
Results First Posted
September 4, 2009
Record last verified: 2015-02