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

This study has been terminated.
Information provided by:
J. Uriach and Company Identifier:
First received: September 9, 2005
Last updated: October 19, 2006
Last verified: December 2005
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
Drug: Rupatadine
Drug: Hydroxyzine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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

Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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Please refer to this study by its identifier: NCT00162786

Brain and Behaviour Institute
Maastricht, Netherlands, 6229 ET
Sponsors and Collaborators
J. Uriach and Company
Principal Investigator: Erik Vuurman, PhD Maastricht University, Brain and Behaviour Institute
  More Information Identifier: NCT00162786     History of Changes
Other Study ID Numbers: DM02RUP/IV/04
Study First Received: September 9, 2005
Last Updated: October 19, 2006

Keywords provided by J. Uriach and Company:
Driving performance

Additional relevant MeSH terms:
Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents processed this record on May 25, 2017