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

Sanofi264 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

264

Conditions

Rhinitis, Allergic, Perennial

Interventions

FexofenadineDRUG

Fexofenadine: One 30 mg Tablet once daily for two weeks

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (1)

Sanofi-aventis administrative office

Makati City, Philippines

Outcomes

Primary Outcomes

Patient's assessment of symptoms and drug activity (Total symptom scores)

Time frame: At baseline, D 7 and D 14

Physician's assessment of symptoms and drug activity (Total symptom scores)

Time frame: At D 14

Secondary Outcomes

AE and SAE collection

Time frame: From the signature of the informed consent up to the end of the study

Data from ClinicalTrials.gov

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