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

February 18, 2015 updated by: UCB Pharma

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, 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
    • Georgia
      • Albany, Georgia, United States
      • Gainesville, Georgia, United States
    • Illinois
      • Normal, Illinois, United States
    • Missouri
      • Bridgeton, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • South Carolina
      • Barnwell, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Kingsport, Tennessee, 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
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Xyzal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
Time Frame: Baseline, 14 days
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
Time Frame: Baseline, 14 days
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
Time Frame: Baseline, 14 days
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
Time Frame: Baseline, 14 days
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
Time Frame: Baseline, 14 days
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)
Time Frame: Baseline, 14 days
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)
Time Frame: 7 days
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)
Time Frame: 14 days
The QT interval refers to the respective time interval in the Electrocardiogram (ECG)
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
Time Frame: Baseline, 14 days
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
Time Frame: Baseline, 14 days
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)
Time Frame: Baseline, 14 days
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
Time Frame: Baseline, 14 days
Baseline, 14 days
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
Time Frame: Baseline, 14 days
Baseline, 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00423
  • RPCE08K2403
  • 2007-003458-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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