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
NCT ID: NCT00619801
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
173 participants
INTERVENTIONAL
2008-03-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
Levocetirizine
Levocetirizine
Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
Interventions
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Levocetirizine
Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks
Placebo
Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
6 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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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
Countries
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References
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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.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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RPCE07K2404
Identifier Type: -
Identifier Source: secondary_id
2015-000205-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A00426
Identifier Type: -
Identifier Source: org_study_id
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