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…
ID
Bron
Verkorte titel
Aandoening
allergic rhinitis
Sedation
antihistamine
Bilastine
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Standard deviation of the lateral position (SDLP) in the Road Tracking test on day 1 and 8.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Day one and day 8 of each of four periods are testdays.
Onderzoeksproduct en/of interventie
1. Bilastine 20 mg;
2. Bilastine 40 mg;
3. Placebo;
4. Active control: hydroxyzine.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1635 |
| NTR-old | NTR1732 |
| Ander register | : Bila 2707/UMA |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |