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

Phase 4

Terminated

• Conditions: Healthy

• Registration Number: NCT00162786
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-13
• Study Completion: 2005-11
• Status Verified: 2005-12
• Last Update Submitted: 2006-10-19
• Last Update Posted: 2006-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Actual driving performance

Secondary Outcome Measures

Name	Time	Method
Daytime sleepiness
Subjective sleepiness
Alertness

Trial Locations

Locations (1)

Brain and Behaviour Institute; 🇳🇱 Maastricht, Netherlands