Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
Information source: J. Uriach and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Rupatadine (Drug); Hydroxyzine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: J. Uriach and Company Official(s) and/or principal investigator(s):
Erik Vuurman, PhD, Principal Investigator, Affiliation: Maastricht University, Brain and Behaviour Institute
Summary
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.
Clinical Details
Official title: Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
Study design: Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study
Primary outcome: Actual driving performance
Secondary outcome: Daytime sleepinessSubjective sleepiness Alertness
Detailed 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
Eligibility
Minimum age: 21 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Brain and Behaviour Institute, Maastricht 6229 ET, Netherlands
Additional Information
Starting date: May 2005
Ending date: November 2005
Last updated: October 19, 2006
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