Meclizine Plasma Levels in Responders and Non-responders

Seasickness Clinical Trial

Official title:

Meclizine Plasma Levels in Responders and Non-responders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04482985
• Other study ID #: 2020-2019
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2020
• Source: Medical Corps, Israel Defense Force
• Contact: Yoni Evgeni Gutkovich, M.D/Ph.D
• Phone: +972526894497
• Email: gutkovichj[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meclizine
• Motion Sickness
• Seasickness

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meclizine plasma levels	ng/dl	2 hours after meclizine administration