HealthyPhase 4NCT00162786
Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
A Phase 4 study testing Rupatadine and Hydroxyzine in people with Healthy, run by J. Uriach and Company at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rupatadine and Hydroxyzine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2005to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy males or females
- Subjects must be experienced drivers.
- Vision: normal binocular acuity, corrected, or uncorrected.
Who cannot join
- 1. Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Rupatadine, Hydroxyzine, Placebo
- Keywords
- Driving performance, Antihistamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RupatadineDrug
HydroxyzineDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual driving performance
Secondary outcomes (3)
Daytime sleepiness
Subjective sleepiness
Alertness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- J. Uriach and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erik Vuurman, PhD, Principal investigator, Maastricht University, Brain and Behaviour Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162786
- Sponsor's protocol ID
- DM02RUP/IV/04
- Status last verified
- Dec 2005
- First submitted
- 9 Sep 2005
- Last updated
- 20 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
- ClinicalTrials.gov ID
- NCT00162786
- Acronym / sponsor ID
- DM02RUP/IV/04
- Conditions
- Healthy
- Keywords
- Driving performance, Antihistamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- J. Uriach and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Nov 2005
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal healthy males or females
- Subjects must be experienced drivers.
- Vision: normal binocular acuity, corrected, or uncorrected.
Key exclusion criteria (1 listed)
- 1. Pregnant or nursing females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rupatadine | Drug | – |
| Hydroxyzine | Drug | – |
| Placebo | Drug | – |
Primary outcome
Actual driving performance
3 secondary outcomes
Daytime sleepiness
Subjective sleepiness
Alertness
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Vuurman, PhD principal investigator
Maastricht University, Brain and Behaviour Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rupatadine and Hydroxyzine in people with Healthy, run by J. Uriach and Company at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual driving performance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2006.