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

Tracking Information

First Received Date ^ICMJE

August 22, 2008

Last Updated Date

September 14, 2009

Start Date ^ICMJE

March 2002

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Patient's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At baseline, D 7 and D 14 ] [ Designated as safety issue: No ]
Physician's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At D 14 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00741897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AE and SAE collection [ Time Frame: From the signature of the informed consent up to the end of the study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Rhinitis, Allergic, Perennial

Intervention ^ICMJE

Drug: Fexofenadine

Study Arms / Comparison Groups

Experimental: Fexofenadine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

264

Completion Date

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

6 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Philippines

Administrative Information

NCT ID ^ICMJE

NCT00741897

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

M016455C_4001

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Carmela Pagunsan

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

September 2009

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