Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers’ performance on a standard over-the-road driving test and a car-following test...
Brief Summary
Official Title: “Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance”
The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers’ performance on a standard over-the-road driving test and a car-following test.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Detailed Clinical Trial Description
The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows. - Rupatadine - Hydroxyzine - Placebo
Intervention(s) in this Clinical Trial
- Drug: Rupatadine
- Drug: Hydroxyzine
- Drug: Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Actual driving performance
Secondary Measures
- Daytime sleepiness
- Subjective sleepiness
- Alertness
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1. Normal healthy males or females
- 2. Subjects must be experienced drivers.
- 3. Vision: normal binocular acuity, corrected, or uncorrected.
Exclusion Criteria:
- 1. Pregnant or nursing females.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 35 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: J. Uriach and Company Industry
Overall Clinical Trial Officials and Contacts
Erik Vuurman, PhD Principal Investigator Maastricht University, Brain and Behaviour Institute
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162786
Study ID Number: DM02RUP/IV/04
ClinicalTrials.gov Identifier: NCT00162786
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00162786
