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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: August 22, 2008
Last updated: September 14, 2009
Last verified: September 2009
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:

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
Drug: Fexofenadine
Fexofenadine: One 30 mg Tablet once daily for two weeks


Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00741897

Sanofi-aventis administrative office
Makati City, Philippines
Sponsors and Collaborators
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, Allergic, Perennial
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016