Meclizine Plasma Levels in Responders and Non-responders

NCT ID: NCT04482985

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Seasickness Meclizine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meclizine responders

Group Type ACTIVE_COMPARATOR

Meclizine Hydrochloride

Intervention Type DRUG

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

Meclizine non responders

Group Type ACTIVE_COMPARATOR

Meclizine Hydrochloride

Intervention Type DRUG

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

Interventions

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Meclizine 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.

Intervention Type DRUG

Other Intervention Names

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Bonine

Eligibility Criteria

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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

* Known hearing loss or any vestibular impairment
* Vertigo complains
* Any ear infection
* Use of Scopolamine based anti-seasickness drugs.
* Use of meclizine 50mg.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Corps, Israel Defense Force

OTHER

Sponsor Role lead

Responsible Party

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Yoni Gutkovich

deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yoni Evgeni Gutkovich, M.D/Ph.D

Role: CONTACT

+972526894497

Dror Tal, Ph.D

Role: CONTACT

+972549096080

References

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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.

Reference Type BACKGROUND
PMID: 21163711 (View on PubMed)

Other Identifiers

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2020-2019

Identifier Type: -

Identifier Source: org_study_id

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