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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 sleepiness

Subjective 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

Page last updated: June 20, 2008

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