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

This study has been terminated.
Sponsor:
Information provided by:
J. Uriach and Company
ClinicalTrials.gov Identifier:
NCT00162786
First received: September 9, 2005
Last updated: October 19, 2006
Last verified: December 2005
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance

Resource links provided by NLM:

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:

  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.

  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

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

Keywords provided by J. Uriach and Company:
Driving performance
Antihistamine

Additional relevant MeSH terms:
Hydroxyzine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
 Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013