Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Rupatadine Drug: Hydroxyzine Drug: Placebo	Phase IV

ChemIDplus related topics:

Hydroxyzine Hydroxyzine dihydrochloride Hydroxyzine pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study

Official Title:	Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance

Further study details as provided by J. Uriach and Company:

Primary Outcome Measures:

Actual driving performance

Secondary Outcome Measures:

Daytime sleepiness
Subjective sleepiness
Alertness

Estimated Enrollment:	20
Study Start Date:	May 2005
Estimated Study Completion Date:	November 2005

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

Ages Eligible for Study:	21 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal healthy males or females
Subjects must be experienced drivers.
Vision: normal binocular acuity, corrected, or uncorrected.

Exclusion Criteria:

1. Pregnant or nursing females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162786

Locations


Netherlands
	Brain and Behaviour Institute
	Maastricht, Netherlands, 6229 ET

Sponsors and Collaborators

J. Uriach and Company

Investigators


Principal Investigator:	Erik Vuurman, PhD	Maastricht University, Brain and Behaviour Institute

More Information

Study ID Numbers:	DM02RUP/IV/04
First Received:	September 9, 2005
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00162786
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by J. Uriach and Company:

Driving performance

Antihistamine

Study placed in the following topic categories:

Hydroxyzine

Histamine phosphate

Healthy

Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Histamine Antagonists

Therapeutic Uses

Physiological Effects of Drugs

Histamine Agents

Histamine H1 Antagonists

Antipruritics

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	J. Uriach and Company
Information provided by:	J. Uriach and Company
ClinicalTrials.gov Identifier:	NCT00162786