Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
Information source: UCB
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis; Chronic Urticaria
Intervention: Levocetirizine (Drug); Placebo (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: UCB Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
Overall contact:
UCB Clinical Trial Call Center, Phone: +1-877-822-9493
Summary
The purpose of this study is to determine the safety of the oral formulation of
levocetirizine in children ages 6-11 months who suffer from atopic disease.
Clinical Details
Official title: A Multi-Center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 to 11 Months.
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 6 months to 11 months.
Eligibility
Minimum age: 6 Months.
Maximum age: 11 Months.
Gender(s): Both.
Criteria:
To be eligible to participate in this study, all of the following criteria must be met.
- Outpatient, male or female pediatric subject, aged from 6 to 11 months (6 months - < 1
year) at the randomization visit.
- The subject must present at least one of the following symptoms, most commonly
associated with allergic rhinitis.
- 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.
- 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 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.
- Sibling with sleep apnea or sudden infant death syndrome (SIDS).
- Exposure to other conditions known to be potential risk factors for SIDS, such as but
not limited to (this should be determined on a case by case basis taking into account
the subject's entire medical history and environmental living conditions):
- Mothers who smoked or abused drugs during pregnancy.
- Extremely young mothers (defined as age 19 or younger when pregnant).
- Children currently exposed to a caregiver which is a heavy cigarette smoker
(defined as smoking at least a pack of cigarettes per day).
- babies who sleep regularly on their face or are not put to sleep on their backs.
- Premature birth gestational age ≤ 37 weeks) or low birth weight (below 10
percentile for gestational age).
Locations and Contacts
UCB Clinical Trial Call Center, Phone: +1-877-822-9493
Birmingham, Alabama, United States; Recruiting
LITTLE ROCK, Arkansas, United States; Recruiting
HOT SPRINGS, Arkansas, United States; Recruiting
Little Rock, Arkansas, United States; Recruiting
Stockton, California, United States; Recruiting
Orange, California, United States; Recruiting
Huntington Beach, California, United States; Recruiting
Bakersfield, California, United States; Recruiting
Crescent City, California, United States; Recruiting
Los Angeles, California, United States; Recruiting
Gainesville, Georgia, United States; Recruiting
Normal, Illinois, United States; Recruiting
Bridgeton, Missouri, United States; Recruiting
Omaha, Nebraska, United States; Recruiting
Oklahoma City, Oklahoma, United States; Recruiting
Spartanburg, South Carolina, United States; Recruiting
BARNWELL, South Carolina, United States; Recruiting
KINGSPORT, Tennessee, United States; Recruiting
San Antonio, Texas, United States; Recruiting
Dallas, Texas, United States; Recruiting
El Paso, Texas, United States; Recruiting
Sugarland, Texas, United States; Recruiting
RICHMOND, Virginia, United States; Recruiting
Additional Information
Starting date: March 2008
Ending date: August 2008
Last updated: July 9, 2008
|
