Meclizine Plasma Levels in Responders and Non-responders

M

Medical Corps, Israel Defense Force

Status and phase

Unknown
Phase 4

Conditions

Seasickness
Meclizine

Treatments

Drug: Meclizine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT04482985
2020-2019

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Meclizine responders
Active Comparator group
Treatment:
Drug: Meclizine Hydrochloride
Meclizine non responders
Active Comparator group
Treatment:
Drug: Meclizine Hydrochloride

Trial contacts and locations

0

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Central trial contact

Yoni Evgeni Gutkovich, M.D/Ph.D; Dror Tal, Ph.D

Data sourced from clinicaltrials.gov

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