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NCT00520754 Clinical Trial

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Cough Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00520754
Other study ID # A00315
Secondary ID
Status Completed
Phase Phase 2
First received August 24, 2007
Last updated December 11, 2013
Start date December 2001
Est. completion date March 2003

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 2003
Est. primary completion date March 2003
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 24 Months
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• levocetirizine dihydrochloride

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

References & Publications (1)

Cranswick N, Turzíkova J, Fuchs M, Hulhoven R. Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile. Int J Clin Pharmacol Ther. 2005 Apr;43(4):172-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The efficacy based on daily record cards recordings 90 days
Secondary Safety and pharmacokinetics at 90 days; skin reactivity
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