Meclizine Plasma Levels in Responders and Non-responders

Phase 4

• Conditions: Meclizine; Seasickness
• Interventions: Drug: Meclizine Hydrochloride

• Registration Number: NCT04482985
• Lead Sponsor: Medical Corps, Israel Defense Force

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-19
• Last Update Submitted: 2020-07-19
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Study Start: 2020-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meclizine non responders	Meclizine Hydrochloride	-
Meclizine responders	Meclizine Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Meclizine plasma levels	2 hours after meclizine administration	ng/dl