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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162786

Enrollment

Registered

2005-09-13

Start date

2005-05-31

Completion date

2005-11-30

Last updated

2006-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Driving performance, Antihistamine

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.

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

Interventions

DRUGRupatadine

DRUGHydroxyzine

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to 35 Years

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.

Design outcomes

Primary

Measure	Time frame
Actual driving performance	—

Secondary

Measure	Time frame
Daytime sleepiness	—
Subjective sleepiness	—
Alertness	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026