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

NCT ID: NCT00520754

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-03-31

Brief Summary

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

Detailed Description

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Conditions

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Cough

Keywords

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levocetirizine dihydrochloride Xyzal tablets

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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levocetirizine dihydrochloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

References

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Cranswick N, Turzikova 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. doi: 10.5414/cpp43172.

Reference Type RESULT
PMID: 15966463 (View on PubMed)

Other Identifiers

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A00315

Identifier Type: -

Identifier Source: org_study_id