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
  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:


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
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

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 September 18, 2014