Meclizine Plasma Levels in Responders and Non-responders
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2020
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJuly 23, 2020
July 1, 2020
1 year
July 19, 2020
July 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Meclizine plasma levels
ng/dl
2 hours after meclizine administration
Study Arms (2)
Meclizine responders
ACTIVE COMPARATORMeclizine non responders
ACTIVE COMPARATORInterventions
Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known hearing loss or any vestibular impairment
- Vertigo complains
- Any ear infection
- Use of Scopolamine based anti-seasickness drugs.
- Use of meclizine 50mg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 21163711BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.
Study Record Dates
First Submitted
July 19, 2020
First Posted
July 23, 2020
Study Start
September 1, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
July 23, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share