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

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741897
• Other study ID #: M016455C_4001
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2008
• Last updated: September 14, 2009
• Start date: March 2002

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Fexofenadine
Fexofenadine: One 30 mg Tablet once daily for two weeks

Locations

Country	Name	City	State
Philippines	Sanofi-aventis administrative office	Makati City

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's assessment of symptoms and drug activity (Total symptom scores)		At baseline, D 7 and D 14	No
Primary	Physician's assessment of symptoms and drug activity (Total symptom scores)		At D 14	No
Secondary	AE and SAE collection		From the signature of the informed consent up to the end of the study	No