Healthy VolunteersPhase 4NCT01496911
Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving
A Phase 4 study testing Levocetirizine and Hydroxyzine in people with Healthy Volunteers, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial summary
Antihistamines are commonly used and currently levocetirizine is most frequently prescribed in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems, especially to open tubal passage. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Levocetirizine and Hydroxyzine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to Oct 2012
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male healthy volunteer
- He is aged between 18 and 55 years old
- BMI between 18 and 30
- Written informed consent
- Normal static binocular acuity, corrected or uncorrected
- Normal hearing
- Possession of a valid divers certificate and medical fit for diving
- Be considered as reliable and mentally capable of adhering to the protocol.
Who cannot join
- Female
- Current drug use
- Use of psychoactive medication, including antihistamines
- Prior enrolment in the same study
- Physical or mental illness
- Excessive alcohol use (>21 alcoholic drinks per week)
- Intake of caffeine-containing beverages over 5 glasses per day
- Smoker
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Royal Netherlands Navy
Den Helder, North Holland, 1780CA
About this study
Official title: Study to Investigate the Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving at 2 Bar and 4 Bar in Professional Navy Divers
Antihistamines are commonly used and currently levocetirizine is most frequently prescribed in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems, especially to open tubal passage. However, the effects of these drugs on cognitive performance have not been investigated during diving.The objective of this study is to investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and psychomotor functioning during controlled simulated diving in a hyperbaric chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that hydroxyzine will produce significant impairment, and that the magnitude of impairment is related to hyperbaric pressure.
Read the detailed description
This double-blind, randomized, placebo-controlled cross-over study will comprise of 1 training day and 3 test days. Twenty-four healthy male divers from the Royal Netherlands Navy will participate in this study.The objective of this study is to investigate the single dose effects of levocetirizine (5 mg), hydroxyzine (50 mg) and placebo.
Visit 1 is a training day, and Visit 2-4 are test days. At the test day, subjects receive one of the three medications. One hour after administration of the drugs, subjects will start with the dive in the recompression chamber. After one hour, medication has reached their peak plasma concentration, and effects can be expected. There will be a wash-out period of at least 7 days between the test days.
Subjects will perform one simulated dive at each test day. They first descend in 2 min to a pressure of 4 bar (30 mt), stay for 20 min, the dive continues when they ascend to a pressure of 2 bar (10 mt) with another stay for 20 min. At both depths the 20 min periods are the measuring period to perform the test. At the end they will go to the surface according the decompression profile and stop for 3 min at 9 mt, 8 min at 6 mt and 23 min at 3 mt. These decompression stops are regular for the profile and necessary to prevent decompression sickness.Before and after diving, and at 2 and 4 bar, tests measuring attention, memory, psychomotor, concentration and comprehension ability of the participants are conducted.
- Conditions
- Healthy Volunteers
- Being tested
- Levocetirizine, Hydroxyzine, Placebo
- Keywords
- Diving, Drugs, Antihistamines, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
a single oral dose of 5 mg
HydroxyzineDrug
a single oral dose of 50 mg
PlaceboDrug
a single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine (5 mg) | Experimental | Not described Receives: Drug: Levocetirizine |
| Hydroxyzine (50 mg) | Active comparator | Not described Receives: Drug: Hydroxyzine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of errors on the cognitive tests
Measured: acute (up to 3.5 hours after treatment administration)
Secondary outcomes (1)
Reaction speed on the cognitive tests
Measured: acute (up to 3.5 hours after treatment administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Netherlands Navy
- Responsible party
- Principal investigator, Dr Joris C Verster, Utrecht Institute for Pharmaceutical Sciences
- Investigators
- Joris Verster, PhD, Principal investigator, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496911
- Sponsor's protocol ID
- 10-206G/E
- Status last verified
- Nov 2013
- First submitted
- 19 Dec 2011
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving at 2 Bar and 4 Bar in Professional Navy Divers
- ClinicalTrials.gov ID
- NCT01496911
- Acronym / sponsor ID
- 10-206G/E
- Conditions
- Healthy Volunteers
- Keywords
- Diving, Drugs, Antihistamines, Performance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- Collaborators
- Royal Netherlands Navy
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Dec 2011 (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.
Antihistamines are commonly used and currently levocetirizine is most frequently prescribed in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems, especially to open tubal passage. However, the effects of these drugs on cognitive performance have not been investigated during diving.The objective of this study is to investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and psychomotor functioning during controlled simulated diving in a hyperbaric chamber in professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that hydroxyzine will produce significant impairment, and that the magnitude of impairment is related to hyperbaric pressure.
Detailed description
This double-blind, randomized, placebo-controlled cross-over study will comprise of 1 training day and 3 test days. Twenty-four healthy male divers from the Royal Netherlands Navy will participate in this study.The objective of this study is to investigate the single dose effects of levocetirizine (5 mg), hydroxyzine (50 mg) and placebo.
Visit 1 is a training day, and Visit 2-4 are test days. At the test day, subjects receive one of the three medications. One hour after administration of the drugs, subjects will start with the dive in the recompression chamber. After one hour, medication has reached their peak plasma concentration, and effects can be expected. There will be a wash-out period of at least 7 days between the test days.
Subjects will perform one simulated dive at each test day. They first descend in 2 min to a pressure of 4 bar (30 mt), stay for 20 min, the dive continues when they ascend to a pressure of 2 bar (10 mt) with another stay for 20 min. At both depths the 20 min periods are the measuring period to perform the test. At the end they will go to the surface according the decompression profile and stop for 3 min at 9 mt, 8 min at 6 mt and 23 min at 3 mt. These decompression stops are regular for the profile and necessary to prevent decompression sickness.Before and after diving, and at 2 and 4 bar, tests measuring attention, memory, psychomotor, concentration and comprehension ability of the participants are conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine (5 mg) | Experimental | Drug: Levocetirizine |
| Hydroxyzine (50 mg) | Active comparator | Drug: Hydroxyzine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- male healthy volunteer
- He is aged between 18 and 55 years old
- BMI between 18 and 30
- Written informed consent
- Normal static binocular acuity, corrected or uncorrected
Key exclusion criteria (8 listed)
- Female
- Current drug use
- Use of psychoactive medication, including antihistamines
- Prior enrolment in the same study
- Physical or mental illness
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 |
|---|---|---|
| Levocetirizinea single oral dose of 5 mg | Drug | Levocetirizine (5 mg) |
| Hydroxyzinea single oral dose of 50 mg | Drug | Hydroxyzine (50 mg) |
| Placeboa single oral dose | Drug | Placebo |
Primary outcome
Number of errors on the cognitive tests
Time frame: acute (up to 3.5 hours after treatment administration)
1 secondary outcome
Reaction speed on the cognitive tests
Time frame: acute (up to 3.5 hours after treatment administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Screening Protocol
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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.
Joris Verster, PhD principal investigator
Utrecht University
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 Levocetirizine and Hydroxyzine in people with Healthy Volunteers, run by Utrecht Institute for Pharmaceutical Sciences 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 6 Nov 2013. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of errors on the cognitive tests (time frame: acute (up to 3.5 hours after treatment administration)). 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 6 Nov 2013.