Back to resultsFexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Fexofenadine
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial
Eligibility Criteria
Inclusion Criteria:
- Children who manifest allergic rhinitis symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat and/or itchy/watery/red eyes.
Sites / Locations
- Sanofi-aventis administrative office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Fexofenadine
Outcomes
Primary Outcome Measures
Patient's assessment of symptoms and drug activity (Total symptom scores)
Physician's assessment of symptoms and drug activity (Total symptom scores)
Secondary Outcome Measures
AE and SAE collection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00741897
Brief Title
Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Fexofenadine
Intervention Type
Drug
Intervention Name(s)
Fexofenadine
Intervention Description
Fexofenadine: One 30 mg Tablet once daily for two weeks
Primary Outcome Measure Information:
Title
Patient's assessment of symptoms and drug activity (Total symptom scores)
Time Frame
At baseline, D 7 and D 14
Title
Physician's assessment of symptoms and drug activity (Total symptom scores)
Time Frame
At D 14
Secondary Outcome Measure Information:
Title
AE and SAE collection
Time Frame
From the signature of the informed consent up to the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children who manifest allergic rhinitis symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat and/or itchy/watery/red eyes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmela Pagunsan
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis administrative office
City
Makati City
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis
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