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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00741897

First received: August 22, 2008

Last updated: September 14, 2009

Last verified: September 2009

History of Changes

Purpose

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	Intervention	Phase
Rhinitis, Allergic, Perennial	Drug: Fexofenadine	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

Drug Information available for: Fexofenadine Fexofenadine hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Patient's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At baseline, D 7 and D 14 ] [ Designated as safety issue: No ]
Physician's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At D 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AE and SAE collection [ Time Frame: From the signature of the informed consent up to the end of the study ] [ Designated as safety issue: No ]


Enrollment:	264
Study Start Date:	March 2002
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Fexofenadine	Drug: Fexofenadine Fexofenadine: One 30 mg Tablet once daily for two weeks

Eligibility


Ages Eligible for Study:	6 Years to 11 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741897

Locations


Philippines
Sanofi-aventis administrative office
Makati City, Philippines

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Carmela Pagunsan	Sanofi

More Information


Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00741897 History of Changes
Other Study ID Numbers:	M016455C_4001
Study First Received:	August 22, 2008
Last Updated:	September 14, 2009
Health Authority:	Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases	Fexofenadine Terfenadine Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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