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CompletedNCT00619801PALUpdated Mar 6, 2015Results posted

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

A Phase 3 interventional study of Levocetirizine and Placebo in Allergic Rhinitis and Chronic Urticaria, sponsored by UCB Pharma. Completed at 28 sites in United States. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
173
Allocation
Randomized
Ages
2 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinitis
  • Chronic Urticaria

Keywords

  • Xyzal
  • Levocetirizine
  • Allergy
  • Children
  • Seasonal Allergies
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 173 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
173 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Levocetirizine

    Drug: Levocetirizine

Interventions

  • DrugLevocetirizine

    Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks

    Also known as: Xyzal

  • DrugPlacebo

    Placebo oral drops (5 drops) dosed twice a day for 2 weeks.

06

What researchers measure

Primary outcomes

  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

    The RR interval refers to the respective time interval in the Electrocardiogram (ECG).

    Time frame: Baseline, 14 days

  3. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval

    The PR interval refers to the respective time interval in the Electrocardiogram (ECG).

    Time frame: Baseline, 14 days

  4. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration

    The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).

    Time frame: Baseline, 14 days

  5. Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval

    The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

    Time frame: Baseline, 14 days

  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)

    The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

    Time frame: Baseline, 14 days

  7. Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)

    The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

    Time frame: 7 days

  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)

    The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

    Time frame: 14 days

Secondary outcomes

  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

07

Results

Posted Sep 4, 2009

Participant flow

Participant flow — Overall Study
MilestonePlaceboLevocetirizine
Started59114
Safety population59114
Completed58111
Not completed13
Withdrew: Lack of efficacy01
Withdrew: Withdrawal by subject11
Withdrew: Loss of efficacy01

Outcome measures

PrimaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
Time frame:
Baseline, 14 days
Reported as:
Mean · beats per minute
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
beats per minutePlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)-1.5 ± 14.11.3 ± 14.2
PrimaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval

The RR interval refers to the respective time interval in the Electrocardiogram (ECG).

Time frame:
Baseline, 14 days
Reported as:
Mean · milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
millisecondsPlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval9.2 ± 85.9-6.9 ± 83.4
PrimaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval

The PR interval refers to the respective time interval in the Electrocardiogram (ECG).

Time frame:
Baseline, 14 days
Reported as:
Mean · milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
millisecondsPlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval0.5 ± 9.6-0.8 ± 11.0
PrimaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration

The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).

Time frame:
Baseline, 14 days
Reported as:
Mean · milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
millisecondsPlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration0.3 ± 6.60.9 ± 7.1
PrimaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval

The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

Time frame:
Baseline, 14 days
Reported as:
Mean · milliseconds
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
millisecondsPlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval-2.8 ± 17.2-1.5 ± 19.2
PrimaryChange 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)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

Time frame:
Baseline, 14 days
Reported as:
Mean · milliseconds
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)
millisecondsPlaceboLevocetirizine
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)-5.5 ± 14.3-0.3 ± 16.6
PrimaryAbsolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

Time frame:
7 days
Reported as:
Mean · milliseconds
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)
millisecondsPlaceboLevocetirizine
Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)372.6 ± 16.5368.9 ± 19.4
PrimaryAbsolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG).

Time frame:
14 days
Reported as:
Mean · milliseconds
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)
millisecondsPlaceboLevocetirizine
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)369.8 ± 17.1370.5 ± 18.5
SecondaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
Time frame:
Baseline, 14 days
Reported as:
Median · micromole per liter [µmol/L]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
micromole per liter [µmol/L]PlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin0.000 (-10.26 to 3.42)0.000 (-8.55 to 5.13)
SecondaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
Time frame:
Baseline, 14 days
Reported as:
Median · unit per liter [U/L]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
unit per liter [U/L]PlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)-1.5 (-12 to 167)1.0 (-21 to 138)
SecondaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
Time frame:
Baseline, 14 days
Reported as:
Median · unit per liter [U/L]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
unit per liter [U/L]PlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)-1.0 (-15 to 52)1.0 (-16 to 58)
SecondaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
Time frame:
Baseline, 14 days
Reported as:
Median · millimole per liter [mmol/L]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
millimole per liter [mmol/L]PlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen-0.1785 (-2.142 to 2.142)0.0000 (-3.570 to 3.213)
SecondaryChange From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
Time frame:
Baseline, 14 days
Reported as:
Median · micromole per liter [µmol/L]
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
micromole per liter [µmol/L]PlaceboLevocetirizine
Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine-0.8840 (-17.680 to 13.260)1.7680 (-15.912 to 16.796)

Adverse events

Collected over Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/59 (0%)21/59 (35.6%)
Levocetirizine—1/114 (0.9%)39/114 (34.2%)
Most frequent serious events
Most frequent serious events
EventPlaceboLevocetirizine
PyrexiaGeneral disorders0/591/114
Most frequent other events
Showing 10 of 55
Most frequent other events
EventPlaceboLevocetirizine
CoughRespiratory, thoracic and mediastinal disorders5/594/114
Psychomotor hyperactivityNervous system disorders3/590/114
PyrexiaGeneral disorders1/595/114
DiarrhoeaGastrointestinal disorders2/594/114
VomitingGastrointestinal disorders2/594/114
Upper respiratory tract infectionInfections and infestations2/593/114
SinusitisInfections and infestations2/591/114
Viral upper respiratory tract infectionInfections and infestations2/591/114
SomnolenceNervous system disorders2/591/114
Otitis mediaInfections and infestations0/593/114

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboLevocetirizineTotal
<=18 years59114173
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)PlaceboLevocetirizineTotal
Mean3.75 ± 1.453.78 ± 1.383.77 ± 1.40
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboLevocetirizineTotal
Female234972
Male3665101
Region of Enrollment
Region of Enrollment(participants)PlaceboLevocetirizineTotal
United States59114173
08

Study locations

28 sites
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • 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
  • Denver, Colorado, United States
  • Pueblo, Colorado, United States
  • Savannah, Georgia, United States
  • Stockbridge, Georgia, United States
  • Normal, Illinois, United States
  • Overlook Park, Kansas, United States
  • Owensboro, Kentucky, United States
  • Metarie, Louisiana, United States
  • Baltimore, Maryland, United States
  • Omaha, Nebraska, United States
  • Papillon, Nebraska, United States
  • Oklahoma City, Oklahoma, United States
  • Medford, Oregon, United States
  • Portland, Oregon, United States
  • Barnwell, South Carolina, United States
  • Charleston, South Carolina, United States
  • Dallas, Texas, United States
  • El Paso, Texas, United States
  • New Braunfels, Texas, United States
  • Richmond, Virginia, United States
09

References and documents

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. PubMed 20819318 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00619801
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Feb 21, 2008
Start date
Mar 2008
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Sep 4, 2009
Last update
Mar 6, 2015

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)
View the source record on ClinicalTrials.gov ↗

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