SeasicknessPhase 4NCT04482985
Meclizine Plasma Levels in Responders and Non-responders
A Phase 4 study testing Meclizine Hydrochloride in people with Seasickness and Meclizine, run by Medical Corps, Israel Defense Force.
Trial summary
Motion sickness is a debilitating condition that can effect many crew members. Meclizine has long been known as an effective anti motion sickness drug. The response to the drug is variable - some are responders, while others are resistant to the drug. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasickness, Meclizine
- What is being tested?
- Meclizine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Seasickness questioner (WIKER) score of 7.
- Subjective functioning at 1 meter sea voyage - 5/10 and lower.
- Subjects who were prescribed 25mg of meclizine.
- Subjects who did not take any other drugs 48 prior to their participation in the study.
Who cannot join
- Known hearing loss or any vestibular impairment
- Vertigo complains
- Any ear infection
- Use of Scopolamine based anti-seasickness drugs.
- Use of meclizine 50mg.
Trial locations and contacts
No sites are listed yet.
About this study
Motion sickness is a debilitating condition that can effect many crew members. Meclizine has long been known as an effective anti motion sickness drug. The response to the drug is variable - some are responders, while others are resistant to the drug. The aim of the present study is to examine whether there is a correlation between meclizine plasma levels and clinical response.
- Conditions
- Seasickness, Meclizine
- Being tested
- Meclizine Hydrochloride
- Keywords
- Seasickness, Plasma Levels, Meclizine
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meclizine HydrochlorideDrug
Also called Bonine
Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.
| Study group | Role | What they receive |
|---|---|---|
| Meclizine responders | Active comparator | Not described Receives: Drug: Meclizine Hydrochloride |
| Meclizine non responders | Active comparator | Not described Receives: Drug: Meclizine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meclizine plasma levels
ng/dl
Measured: 2 hours after meclizine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeasicknessStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoni Gutkovich, Medical Corps, Israel Defense Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482985
- Sponsor's protocol ID
- 2020-2019
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Z, Qian S, Zhang Q, Chow MS. Quantification of meclizine in human plasma by high performance liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Jan 1;879(1):95-9. doi: 10.1016/j.jchromb.2010.11.022. Epub 2010 Dec 1.
PubMed 21163711
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meclizine Plasma Levels in Responders and Non-responders
- ClinicalTrials.gov ID
- NCT04482985
- Acronym / sponsor ID
- 2020-2019
- Conditions
- Seasickness, Meclizine
- Keywords
- Seasickness, Plasma Levels, Meclizine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 23 Jul 2020 (actual)
- 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.
Motion sickness is a debilitating condition that can effect many crew members. Meclizine has long been known as an effective anti motion sickness drug. The response to the drug is variable - some are responders, while others are resistant to the drug. The aim of the present study is to examine whether there is a correlation between meclizine plasma levels and clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meclizine responders | Active comparator | Drug: Meclizine Hydrochloride |
| Meclizine non responders | Active comparator | Drug: Meclizine Hydrochloride |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Seasickness questioner (WIKER) score of 7.
- Subjective functioning at 1 meter sea voyage - 5/10 and lower.
- Subjects who were prescribed 25mg of meclizine.
- Subjects who did not take any other drugs 48 prior to their participation in the study.
Key exclusion criteria (5 listed)
- Known hearing loss or any vestibular impairment
- Vertigo complains
- Any ear infection
- Use of Scopolamine based anti-seasickness drugs.
- Use of meclizine 50mg.
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 |
|---|---|---|
| Meclizine HydrochlorideAlso: BonineMeclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group. | Drug | Meclizine non responders, Meclizine responders |
Primary outcome
Meclizine plasma levels
Time frame: 2 hours after meclizine administration
ng/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 21163711Wang Z, Qian S, Zhang Q, Chow MS. Quantification of meclizine in human plasma by high performance liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Jan 1;879(1):95-9. doi: 10.1016/j.jchromb.2010.11.022. Epub 2010 Dec 1.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meclizine Hydrochloride in people with Seasickness and Meclizine, run by Medical Corps, Israel Defense Force.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoni Evgeni Gutkovich, M.D/Ph.D (+972526894497, gutkovichj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meclizine plasma levels (time frame: 2 hours after meclizine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482985, which also lists 1 linked publication.
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 23 Jul 2020.