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The effects of the antihistamine bilastine on actual driving performance.


- candidate number5487
- NTR NumberNTR1732
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mrt-2009
- Secondary IDsBila 2707/UMA  
- Public TitleThe effects of the antihistamine bilastine on actual driving performance.
- Scientific TitleDouble-blind, randomised, four-way crossover study to assess the effect of two doses of bilastine 20 and 40 mg compared with hydroxyzine 50 mg and placebo on actual driving performance.
- ACRONYMN/A
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedAllergic rhinitis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 4-jun-2008
- planned closingdate1-jun-2009
- Target number of participants20
- Interventions1. Bilastine 20 mg;
2. Bilastine 40 mg;
3. Placebo;
4. Active control: hydroxyzine.
- Primary outcomeStandard deviation of the lateral position (SDLP) in the Road Tracking test on day 1 and 8.
- Secondary outcome1. 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.
- TimepointsDay one and day 8 of each of four periods are testdays.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.G. Ramaekers
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Ramaekers
- Sponsor/Initiator FAES FARMA S.A.
- Funding
(Source(s) of Monetary or Material Support)
FAES FARMA S.A.
- PublicationsN/A
- Brief summaryBilastine 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.
- Main changes (audit trail)
- RECORD20-mrt-2009 - 14-sep-2009


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