Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00637455
First received: March 10, 2008
Last updated: January 10, 2011
Last verified: January 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Compare the AVT overall mean challenge from baseline between Fexofenadine HCl & Cetirizine [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluating change from baseline between Fexofenadine HCl and Cetirizine on the endpoint of total # of errors under each normobaric hypoxic condition

Enrollment: 72
Study Start Date: September 2003
Study Completion Date: January 2005
Intervention Details:
    Drug: fexofenadine HCl
    Other Name: Allegra
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00637455

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Phyllis Diener Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637455     History of Changes
Other Study ID Numbers: M016455A/4139
Study First Received: March 10, 2008
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014