NCT00741897

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

August 22, 2008

Last Update Submit

September 14, 2009

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • AE and SAE collection

    From the signature of the informed consent up to the end of the study

Study Arms (1)

1

EXPERIMENTAL

Fexofenadine

Drug: Fexofenadine

Interventions

FexofenadineDRUG

Fexofenadine: One 30 mg Tablet once daily for two weeks

1

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis administrative office

Makati City, Philippines

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Carmela Pagunsan

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 26, 2008

Study Start

March 1, 2002

Primary Completion

December 1, 2003

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

PH(1)