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

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ClinicalTrials.gov Identifier: NCT00162786
Recruitment Status : Terminated
First Posted : September 13, 2005
Last Update Posted : October 20, 2006
Sponsor:
Information provided by:
J. Uriach and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rupatadine Drug: Hydroxyzine Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
Study Start Date : May 2005
Estimated Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Actual driving performance

Secondary Outcome Measures :
  1. Daytime sleepiness
  2. Subjective sleepiness
  3. Alertness


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00162786     History of Changes
Other Study ID Numbers: DM02RUP/IV/04
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 20, 2006
Last Verified: December 2005

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

Additional relevant MeSH terms:
Hydroxyzine
Cyproheptadine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents