Meclizine Plasma Levels in Responders and Non-responders

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)

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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