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Status unknownNCT04482985Updated Jul 23, 2020

Meclizine Plasma Levels in Responders and Non-responders

A Phase 4 interventional study of Meclizine Hydrochloride in Seasickness and Meclizine, sponsored by Medical Corps, Israel Defense Force. Status unknown. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Medical Corps, Israel Defense Force · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
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Study 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. The aim of the present study is to examine whether there is a correlation between meclizine plasma levels and clinical response.

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Conditions studied

  • Seasickness
  • Meclizine

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Keywords

  • Seasickness
  • Plasma Levels
  • Meclizine
03

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's planned enrollment of 50 is below the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Known hearing loss or any vestibular impairment
  • Vertigo complains
  • Any ear infection
  • Use of Scopolamine based anti-seasickness drugs.
  • Use of meclizine 50mg.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Meclizine responders

    Drug: Meclizine Hydrochloride

  • Active comparator
    Meclizine non responders

    Drug: Meclizine Hydrochloride

Interventions

  • DrugMeclizine Hydrochloride

    Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.

    Also known as: Bonine

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What researchers measure

Primary outcomes

  1. Meclizine plasma levels

    ng/dl

    Time frame: 2 hours after meclizine administration

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2020; primary completion for Sep 2021, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2020
First posted
Jul 23, 2020
StartEst.
Sep 1, 2020
Primary completionEst.
Sep 1, 2021
CompletionEst.
Sep 1, 2021
Last update
Jul 23, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04482985
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
Yoni Gutkovich (deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa., Medical Corps, Israel Defense Force) — Principal investigator
First posted
Jul 23, 2020
Start date
Sep 1, 2020 (estimated)
Primary completion
Sep 1, 2021 (estimated)
Completion
Sep 1, 2021 (estimated)
Last update
Jul 23, 2020

Study contacts

Yoni Evgeni Gutkovich, M.D/Ph.D
Contact
gutkovichj@gmail.com
+972526894497
Dror Tal, Ph.D
Contact
tldror1@gmail.com
+972549096080

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Meclizine

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Medical Corps, Israel Defense Force

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