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

This study has been terminated.

First Received: September 9, 2005 Last Updated: October 19, 2006 History of Changes

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

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

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

Resource links provided by NLM:

Drug Information available for: Hydroxyzine Hydroxyzine pamoate Rupatadine Hydroxyzine dihydrochloride

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	DM02RUP/IV/04
Study First Received:	September 9, 2005
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00162786 History of Changes
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
Neurotransmitter Agents
Histamine Antagonists
Histamine phosphate

Antipruritics
Histamine H1 Antagonists
Healthy
Histamine

Additional relevant MeSH terms:

Hydroxyzine
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 11, 2009