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

December 11, 2013 updated by: UCB Pharma

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The efficacy based on daily record cards recordings
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Safety and pharmacokinetics at 90 days; skin reactivity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Estimate)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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