Status:

TERMINATED

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

Lead Sponsor:

J. Uriach and Company

Conditions:

Healthy

Eligibility:

All Genders

21-35 years

Phase:

PHASE4

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 o...

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 Criteria

Inclusion

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

Exclusion

  • 1\. Pregnant or nursing females.

Key Trial Info

Start Date :

May 1 2005

Trial Type :

INTERVENTIONAL

End Date :

November 1 2005

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00162786

Start Date

May 1 2005

End Date

November 1 2005

Last Update

October 20 2006

Active Locations (1)

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Brain and Behaviour Institute

Maastricht, Netherlands, 6229 ET