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
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis; Chronic Urticaria
Intervention: Levocetirizine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: UCB Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Primary outcome: To evaluate the safety of levocetirizine in pediatric subjects aged from 1 to less than 6 years.
Eligibility
Minimum age: 1 Year.
Maximum age: 5 Years.
Gender(s): Both.
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.
- Subjects suffering from 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.
Exclusion Criteria:
Subject must be excluded if they meet any of the following criteria. These criteria must be
checked at Screening Visit (V1) and at the Randomization Visit (V2):
- 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 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.
- 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 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.
These treatments are also prohibited during the whole trial period i. e., from Screening
Visit until End of Treatment Visit. In case a wash-out period is needed, the caregivers
should sign the informed consent before stopping any treatment.
- 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.
Locations and Contacts
BIRMINGHAM, Alabama, United States
Birmingham, Alabama, United States
LITTLE ROCK, Arkansas, United States
San Diego, California, United States
Huntington Beach, California, United States
Mission Viejo, California, United States
BEVERLY HILLS, California, United States
WILDOMAR, California, United States
Pueblo, Colorado, United States
DENVER, 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
Charleston, South Carolina, United States
BARNWELL, South Carolina, United States
Dallas, Texas, United States
New Braunfels, Texas, United States
El Paso, Texas, United States
RICHMOND, Virginia, United States
Additional Information
Starting date: March 2008
Ending date: July 2008
Last updated: June 19, 2008
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