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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
1: Experimental 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

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Rhinitis
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases
Hypersensitivity

Terfenadine
Histamine Antagonists
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Fexofenadine
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010