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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00628108
First received: February 22, 2008
Last updated: August 26, 2014
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
Chronic Urticaria
Drug: Levocetirizine 1.25 mg
Other: 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 in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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 interval 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 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 Aminontransferase (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: 69
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo oral liquid once a day for two weeks
Experimental: Levocetirizine Drug: Levocetirizine 1.25 mg
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks
Other Name: Xyzal

  Eligibility

Ages Eligible for Study:   6 Months to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628108

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Bakersfield, California, United States
Crescent City, California, United States
Huntington Beach, California, United States
Los Angeles, California, United States
Orange, California, United States
Roseville, California, United States
Stockton, California, United States
United States, Georgia
Albany, Georgia, United States
Gainesville, Georgia, United States
United States, Illinois
Normal, Illinois, United States
United States, Missouri
Bridgeton, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, South Carolina
Barnwell, South Carolina, United States
Spartanburg, South Carolina, United States
United States, Tennessee
Kingsport, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Sugarland, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided by UCB Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00628108     History of Changes
Other Study ID Numbers: A00423, RPCE08K2403, 2007-003458-28
Study First Received: February 22, 2008
Results First Received: September 9, 2009
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Xyzal
Levocetirizine
Allergy
Children
Seasonal Allergies

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Urticaria
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Skin Diseases
Skin Diseases, Vascular
Cetirizine
Levocetirizine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014