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

Phase 4

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: Fexofenadine

• Registration Number: NCT00741897
• Lead Sponsor: Sanofi

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

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2003-12
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Fexofenadine	Fexofenadine

Primary Outcome Measures

Name	Time	Method
Patient's assessment of symptoms and drug activity (Total symptom scores)	At baseline, D 7 and D 14
Physician's assessment of symptoms and drug activity (Total symptom scores)	At D 14

Secondary Outcome Measures

Name	Time	Method
AE and SAE collection	From the signature of the informed consent up to the end of the study

Trial Locations

Locations (1)

Sanofi-aventis administrative office; 🇵🇭 Makati City, Philippines