- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00637455
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
January 10, 2011 updated by: Sanofi
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female naval flight personnel, ≥18 years of age
- CogScreen-AE Logistic Regression Probability Value < 0.6 at the baseline screening visit
- Normal SaO2 (>95%) as measured by pulse oximetry
- Female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 1 year postmenopausal); see Section 4.4 for additional information:
Exclusion Criteria:
- Female subjects who are pregnant, lactating, or likely to become pregnant during the study
- Signs or symptoms of currently active allergic disease (seasonal allergic rhinitis, perennial allergic rhinitis, episodic allergic rhinitis) within 2 weeks prior to the screening visit
- Upper respiratory tract infection, sinusitis, asthma exacerbation, or flu-like symptoms within 2 weeks prior to the screening visit
- Medical history or physical examination findings; clinically significant cardiovascular, respiratory, hepatic, neurologic, endocrine, psychiatric, or other major systemic disease; or laboratory or electrocardiograph abnormality making implementation of the protocol or interpretation of the protocol results difficult. Abnormalities which are not clinically significant will not necessarily disqualify subjects provided, in the opinion of the investigator and sponsor, the study validity or the subject's welfare is not compromised.
- Any unusual sleep pattern, including third-shift workers (11:00 PM to 7:00 AM), or sleep < 6 hours the night before each AVT testing at Visits 1-4
- Any excessive amounts of alcohol (no more than two drinks/day on average)
- Any excessive use of caffeine (more than three cups of coffee per day or equivalent)
- Any history of chronic alcohol or mood-altering drug abuse
- Any use of tobacco/nicotine products within 90 days of the screening visit or during the study
- Any disease state or surgery known to affect the gastrointestinal absorption of drugs
- Mental capacity limited to the extent the subject cannot give legal informed consent or accurate information regarding efficacy and side effects/tolerance of drug
- Subjects unable to comply with the protocol requirements (must complete a screening visit and Visits 1-4 within approximately 1-1/2 months)
- Known hypersensitivity to fexofenadine, or the tablet ingredients (croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch; or the tablet coating made of hydroxypropyl methylcellulose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide)
- Known hypersensitivity to cetirizine or the tablet ingredients (lactose, magnesium stearate, povidone, titanium dioxide, hydroxypropyl methylcellulose, polyethylene glycol, and corn starch)
- Use of an investigational drug within 30 days prior to Visit 1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Compare the AVT overall mean challenge from baseline between Fexofenadine HCl & Cetirizine
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Secondary Outcome Measures
Outcome Measure |
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Evaluating change from baseline between Fexofenadine HCl and Cetirizine on the endpoint of total # of errors under each normobaric hypoxic condition
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
March 10, 2008
First Submitted That Met QC Criteria
March 17, 2008
First Posted (Estimate)
March 18, 2008
Study Record Updates
Last Update Posted (Estimate)
January 11, 2011
Last Update Submitted That Met QC Criteria
January 10, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Fexofenadine
Other Study ID Numbers
- M016455A/4139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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