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

Phase 2

Completed

• Conditions: Cough

• Registration Number: NCT00520754
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Study First Posted: 2007-08-27
• Status Verified: 2009-09
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The efficacy based on daily record cards recordings	90 days

Secondary Outcome Measures

Name	Time	Method
Safety and pharmacokinetics at 90 days; skin reactivity