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NCT00162786 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00162786
Other study ID # DM02RUP/IV/04
Secondary ID
Status Terminated
Phase Phase 4
First received September 9, 2005
Last updated October 19, 2006
Start date May 2005
Est. completion date November 2005

Study information
Verified date December 2005
Source J. Uriach and Company
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 35 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Rupatadine

• Hydroxyzine

• Placebo

Locations
Country Name City State
Netherlands Brain and Behaviour Institute Maastricht

Sponsors (1)
Lead Sponsor Collaborator
J. Uriach and Company

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Actual driving performance
Secondary Daytime sleepiness
Secondary Subjective sleepiness
Secondary Alertness
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