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

This study has been completed.

Sponsor:

Information provided by:

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00520754

First received: August 24, 2007

Last updated: September 9, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 24, 2007

Last Updated Date

September 9, 2009

Start Date ^ICMJE

December 2001

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The efficacy based on daily record cards recordings [ Time Frame: 90 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00520754 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and pharmacokinetics at 90 days; skin reactivity

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Cough

Intervention ^ICMJE

Drug: levocetirizine dihydrochloride

Study Arm (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2003

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Months to 24 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00520754

Other Study ID Numbers ^ICMJE

A00315

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

Information Provided By

UCB, Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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