Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00741897

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-Aventis:

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
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

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

Locations

Philippines
Sanofi-aventis administrative office
Makati City, Philippines

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Carmela Pagunsan

Sanofi-Aventis

More Information

No publications provided

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, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fexofenadine

Terfenadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
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 May 24, 2012