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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rhinitis, Allergic, Perennial | Drug: Fexofenadine | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Fexofenadine
|
Drug: Fexofenadine
Fexofenadine: One 30 mg Tablet once daily for two weeks |
- Patient's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At baseline, D 7 and D 14 ]
- Physician's assessment of symptoms and drug activity (Total symptom scores) [ Time Frame: At D 14 ]
- AE and SAE collection [ Time Frame: From the signature of the informed consent up to the end of the study ]

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Ages Eligible for Study: | 6 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
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.

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
Philippines | |
Sanofi-aventis administrative office | |
Makati City, Philippines |
Study Director: | Carmela Pagunsan | Sanofi |
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 |