Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cough
Intervention: levocetirizine dihydrochloride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Isabelle Campine, Study Director, Affiliation: UCB
Summary
Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other
Allergic Symptoms in Children
Clinical Details
Official title: The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: The efficacy based on daily record cards recordings
Secondary outcome: Safety and pharmacokinetics at 90 days; skin reactivity
Eligibility
Minimum age: 2 Months.
Maximum age: 24 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- infants from 2 to 24 months both inclusive
- suffering from recurrent cough associated with other allergic symptoms
- hospitalized for respiratory or allergy related problems
- laboratory results within normal ranges
- height and weight between percentile 5 and 95
Exclusion Criteria:
- having taken any of the disallowed medication
- suffering form any disorder
- history of sleep apnea
- having concomitant chronic disease
- known relevant renal, hepatic, cardiac or metabolism dysfunction
- known alcohol or drug addiction, severe psychiatric disease for the parent/guardian
Locations and Contacts
Additional Information
Starting date: December 2001
Ending date: March 2003
Last updated: April 16, 2008
|
