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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

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Chronic Urticaria Drug: Levocetirizine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Study Start Date : March 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

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 Name: Xyzal




Primary Outcome Measures :
  1. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) [ Time Frame: Baseline, 14 days ]
  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).


Secondary Outcome Measures :
  1. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin [ Time Frame: Baseline, 14 days ]
  2. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) [ Time Frame: Baseline, 14 days ]
  3. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST) [ Time Frame: Baseline, 14 days ]
  4. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen [ Time Frame: Baseline, 14 days ]
  5. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine [ Time Frame: Baseline, 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619801


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Little Rock, Arkansas, United States
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
United States, Colorado
Denver, Colorado, United States
Pueblo, Colorado, United States
United States, Georgia
Savannah, Georgia, United States
Stockbridge, Georgia, United States
United States, Illinois
Normal, Illinois, United States
United States, Kansas
Overlook Park, Kansas, United States
United States, Kentucky
Owensboro, Kentucky, United States
United States, Louisiana
Metarie, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Nebraska
Omaha, Nebraska, United States
Papillon, Nebraska, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
Portland, Oregon, United States
United States, South Carolina
Barnwell, South Carolina, United States
Charleston, South Carolina, United States
United States, Texas
Dallas, Texas, United States
El Paso, Texas, United States
New Braunfels, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00619801    
Other Study ID Numbers: A00426
RPCE07K2404
2015-000205-39 ( EudraCT Number )
First Posted: February 21, 2008    Key Record Dates
Results First Posted: September 4, 2009
Last Update Posted: March 6, 2015
Last Verified: February 2015
Keywords provided by UCB Pharma:
Xyzal
Levocetirizine
Allergy
Children
Seasonal Allergies
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Urticaria
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Vascular
Skin Diseases
Levocetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs