NCT00162786

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

October 20, 2006

Status Verified

December 1, 2005

First QC Date

September 9, 2005

Last Update Submit

October 19, 2006

Conditions

Healthy

Keywords

Driving performanceAntihistamine

Outcome Measures

Primary Outcomes (1)

  • Actual driving performance

Secondary Outcomes (3)

  • Daytime sleepiness

  • Subjective sleepiness

  • Alertness

Interventions

RupatadineDRUG
HydroxyzineDRUG
PlaceboDRUG

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal healthy males or females
  • Subjects must be experienced drivers.
  • Vision: normal binocular acuity, corrected, or uncorrected.

You may not qualify if:

  • \. Pregnant or nursing females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain and Behaviour Institute

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Interventions

rupatadineHydroxyzine

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Erik Vuurman, PhD

    Maastricht University, Brain and Behaviour Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

May 1, 2005

Study Completion

November 1, 2005

Last Updated

October 20, 2006

Record last verified: 2005-12

Locations

NL(1)