Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00619801
Previous Study | Return to List | Next Study

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00619801
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : September 4, 2009
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE February 11, 2008
First Posted Date  ICMJE February 21, 2008
Results First Submitted Date  ICMJE July 28, 2009
Results First Posted Date  ICMJE September 4, 2009
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE March 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) [ Time Frame: 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
To evaluate the safety of levocetirizine in pediatric subjects aged from 2-6 years. [ Time Frame: 2 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin [ Time Frame: 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 ]
  • Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST) [ Time Frame: 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 ]
  • Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine [ Time Frame: Baseline, 14 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Allergic Rhinitis
  • Chronic Urticaria
Intervention  ICMJE
  • Drug: Levocetirizine
    Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
    Other Name: Xyzal
  • Drug: Placebo
    Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Levocetirizine
    Intervention: Drug: Levocetirizine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2009)
173
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2008)
150
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00619801
Other Study ID Numbers  ICMJE A00426
RPCE07K2404
2015-000205-39 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP