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

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ClinicalTrials.gov Identifier: NCT00741897
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Fexofenadine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2002
Actual Primary Completion Date : December 2003

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Fexofenadine
 Drug: Fexofenadine
Fexofenadine: One 30 mg Tablet once daily for two weeks


Outcome Measures
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Primary Outcome Measures :
  1. Patient's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At baseline, D 7 and D 14 ]
  2. Physician's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At D 14 ]

Secondary Outcome Measures :
  1. AE and SAE collection [ Time Frame: From the signature of the informed consent up to the end of the study ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741897


Locations
Philippines
Sanofi-aventis administrative office
Makati City, Philippines
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Carmela Pagunsan Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00741897     History of Changes
Other Study ID Numbers: M016455C_4001
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

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