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)

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 b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

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
      • Little Rock, Arkansas, United States
    • California
      • Beverly Hills, California, United States
      • Crescent City, California, United States
      • Huntington Beach, California, United States
      • Mission Viejo, California, United States
      • San Diego, California, United States
      • Wildomar, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Pueblo, Colorado, United States
    • Georgia
      • Savannah, Georgia, United States
      • Stockbridge, Georgia, United States
    • Illinois
      • Normal, Illinois, United States
    • Kansas
      • Overlook Park, Kansas, United States
    • Kentucky
      • Owensboro, Kentucky, United States
    • Louisiana
      • Metarie, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Nebraska
      • Omaha, Nebraska, United States
      • Papillon, Nebraska, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • South Carolina
      • Barnwell, South Carolina, United States
      • Charleston, South Carolina, United States
    • Texas
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • New Braunfels, 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

7 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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)

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 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):

    1. Systemic corticosteroids within the past 28 days
    2. Leukotriene-receptor antagonists (e.g. montelukast [Singulair] or zafirlukast [Accolate] within the past 7 days)
    3. Mast-cell stabilizers (e.g. cromolyn or nedocromil) within the past 7 days
    4. 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
    5. Systemic antibiotics within the past 7 days
    6. 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

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
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 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 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
Time Frame: Baseline, 14 days
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)
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 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
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
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)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 21, 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

  • A00426
  • RPCE07K2404
  • 2015-000205-39 (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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