Healthy elderly volunteers
Conditions
Interventions
Trade Name: Imovane
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Normison
Pharmaceutical Form: Table
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 55 and 75 years 2. Good health, in the opinion of the medical supervisor, on the basis of a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry, haematology, and serology tests, and urinalysis. 3. Possession of a valid driving licence for 3 years or more 4. Driving experience of at least 3000 km per year on average Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of drug or alcohol abuse 2. BMI over 30 kg/m2 3. Chronic use of medication that affects driving performance 4. Smoking more than 10 cigarettes per day 5. Drinking more than 6 cups of coffee per day 6. Drinking more than 21 glasses of alcohol per week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the residual effects of zopiclone 7.5 mg and temazepam 20 mg on actual driving in healthy elderly volunteers.;Secondary Objective: To compare the residual effects of zopiclone 7.5 mg with those in young volunteers, as found recently in a study using the same tests and procedures (Leufkens & Vermeeren, in prep).;Primary end point(s): Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test. SDLP is a measure of road tracking error; in practical terms, it is a composite index of allowed weaving, swerving, and overcorrecting. | — |
Countries
Netherlands
Outcome results
None listed