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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00637455 |
Purpose
To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: fexofenadine HCl |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Single Center, Randomized,Double-Blind,Crossover Study Comparing the Effects of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel |
| Enrollment: | 72 |
| Study Start Date: | September 2003 |
| Study Completion Date: | January 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Study Director ) |
| Study ID Numbers: | MO16455A/4139 |
| Study First Received: | March 10, 2008 |
| Last Updated: | March 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00637455 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Histamine Agents Rhinitis Anti-Allergic Agents Cetirizine Pharmacologic Actions Nose Diseases Hypersensitivity |
Terfenadine Histamine Antagonists Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Rhinitis, Allergic, Seasonal Fexofenadine Hypersensitivity, Immediate Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Respiratory Hypersensitivity |