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

Phase 4TerminatedNCT00162786

J. Uriach and Company20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

RupatadineDRUG

HydroxyzineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Brain and Behaviour Institute

Maastricht, Netherlands

Outcomes

Primary Outcomes

Actual driving performance

Secondary Outcomes

Daytime sleepiness

Subjective sleepiness

Alertness

Data from ClinicalTrials.gov

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