MedDataX Logo

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

NCT ID: NCT00162786

Last Updated: 2006-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Driving performance Antihistamine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rupatadine

Intervention Type DRUG

Hydroxyzine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

J. Uriach and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erik Vuurman, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University, Brain and Behaviour Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brain and Behaviour Institute

Maastricht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DM02RUP/IV/04

Identifier Type: -

Identifier Source: org_study_id