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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00741897
• Collaborator: (none)
• Enrollment: 264
• Location: 1
• Arm: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Perennial	Drug: Fexofenadine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 264 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2002
• Actual Primary Completion Date: Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Fexofenadine	Drug: Fexofenadine; Fexofenadine: One 30 mg Tablet once daily for two weeks

Outcome Measures

Primary Outcome Measures

1. Patient's assessment of symptoms and drug activity (Total symptom scores) [At baseline, D 7 and D 14]

2. Physician's assessment of symptoms and drug activity (Total symptom scores) [At D 14]

Secondary Outcome Measures

1. AE and SAE collection [From the signature of the informed consent up to the end of the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-aventis administrative office	Makati City		Philippines

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Carmela Pagunsan, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00741897
• Other Study ID Numbers: M016455C_4001
• First Posted: Aug 26, 2008
• Last Update Posted: Sep 15, 2009
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Fexofenadine

Study Results

No Results Posted as of Sep 15, 2009