Status:
COMPLETED
Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving
Lead Sponsor:
Utrecht Institute for Pharmaceutical Sciences
Collaborating Sponsors:
Royal Netherlands Navy
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE4
Brief Summary
Antihistamines are commonly used and currently levocetirizine is most frequently prescribed in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems, especially to ...
Detailed Description
This double-blind, randomized, placebo-controlled cross-over study will comprise of 1 training day and 3 test days. Twenty-four healthy male divers from the Royal Netherlands Navy will participate in ...
Eligibility Criteria
Inclusion
- male healthy volunteer
- He is aged between 18 and 55 years old
- BMI between 18 and 30
- Written informed consent
- Normal static binocular acuity, corrected or uncorrected
- Normal hearing
- Possession of a valid divers certificate and medical fit for diving
- Be considered as reliable and mentally capable of adhering to the protocol.
Exclusion
- Female
- Current drug use
- Use of psychoactive medication, including antihistamines
- Prior enrolment in the same study
- Physical or mental illness
- Excessive alcohol use (\>21 alcoholic drinks per week)
- Intake of caffeine-containing beverages over 5 glasses per day
- Smoker
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01496911
Start Date
April 1 2012
End Date
October 1 2012
Last Update
November 6 2013
Active Locations (1)
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1
Royal Netherlands Navy
Den Helder, North Holland, Netherlands, 1780CA