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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

October 19, 2006

Start Date ^ICMJE

May 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Actual driving performance

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00162786 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Daytime sleepiness
Subjective sleepiness
Alertness

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Rupatadine
Drug: Hydroxyzine
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00162786

Responsible Party

Study ID Numbers ^ICMJE

DM02RUP/IV/04

Study Sponsor ^ICMJE

J. Uriach and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Erik Vuurman, PhD

Maastricht University, Brain and Behaviour Institute

Information Provided By

J. Uriach and Company

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP