No registrations found.
ID
Source
Brief title
Health condition
allergic rhinitis
Sedation
antihistamine
Bilastine
Sponsors and support
Intervention
Outcome measures
Primary outcome
Standard deviation of the lateral position (SDLP) in the Road Tracking test on day 1 and 8.
Secondary outcome
1. Standard deviation of Speed (SDSP) in the Road tracking test on day 1 and 8;
2. Safety parameters: clinical signs and symptoms from physical examination, adverse evetns, laboratory safety, vital signs and ECGs.
Background summary
Bilastine is a newly developed antihistamine. The main of the study is to gain more information about the sedative effects of two doses (20 and 40 mg) of bilastine and to assess the effect of repeated dosing on the road driving ability. It is expected that no differences will be detected between bilastine and placebo, and that differences will be detected between bilastine and placebo vs hydroxyzine using the actual driving test.
Study objective
The main of the study is to gain more information about the sedative effects of two doses (20 and 40 mg) of bilastine and to assess the effect of repeated dosing on the road driving ability. It is expected that no differences will be detected between bilastine and placebo, and that differences will be detected between bilastine and placebo vs hydroxyzine.
Study design
Day one and day 8 of each of four periods are testdays.
Intervention
1. Bilastine 20 mg;
2. Bilastine 40 mg;
3. Placebo;
4. Active control: hydroxyzine.
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Inclusion criteria
1. Aged between 21 and 45 years;
2. Healthy volunteers;
3. BMI between 19 and 30;
4. Having a valid driving licence for more than 3 years;
5. Having a driving experience of at least 5000 km per year;
6. Able to give a written informed consent;
7. Able to understand the protocol and to come to the visits;
8. Use of a contraceptive method (for women).
Exclusion criteria
1. Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize their health or is likely to modify their handling of the study drug;
2. Any non corrected visual defect or locomotor disorder which could interfere with the study;
3. Acute or chronic systemic disease or disorder;
4. History of hypersensitivity to H1 antihistamines, benzimidazoles or lactose;
5. Seasonal allergic rhinitis or urticaria treated by antihistamine;
6. History of alcohol abuse.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1635 |
| NTR-old | NTR1732 |
| Other | : Bila 2707/UMA |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |