Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis

September 14, 2009 updated by: Sanofi

A Monitored Release Study On The Efficacy And Safety of Fexofenadine (Telfast®) 30mg Pediatric Tablets On Filipino Children Aged 6 To 11 for The Relief of Perennial And Intermittent Allergic Rhinitis.

To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and intermittent allergic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Makati City, Philippines
        • Sanofi-Aventis Administrative Office

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

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children who manifest allergic rhinitis symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat and/or itchy/watery/red eyes.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Fexofenadine
Drug: Fexofenadine
Fexofenadine: One 30 mg Tablet once daily for two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient's assessment of symptoms and drug activity (Total symptom scores)
Time Frame: At baseline, D 7 and D 14
At baseline, D 7 and D 14
Physician's assessment of symptoms and drug activity (Total symptom scores)
Time Frame: At D 14
At D 14

Secondary Outcome Measures

Outcome Measure
Time Frame
AE and SAE collection
Time Frame: From the signature of the informed consent up to the end of the study
From the signature of the informed consent up to the end of the study

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Carmela Pagunsan, Sanofi

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

March 1, 2002

Primary Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M016455C_4001

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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