Meclizine Plasma Levels in Responders and Non-responders | NCT04482985

Studies
Meclizine Plasma Levels in Responders and Non-responders

NCT04482985

Sponsor

Medical Corps, Israel Defense Force

Status

Unknown status

Last Update Posted

Jul 23, 2020Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Seasickness
Meclizine

Interventions

Meclizine Hydrochloride

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Sep 1, 2021Estimated

First Submitted Date

Jul 19, 2020

First Submission Date that Met QC Criteria

Jul 19, 2020

First Posted Date

Jul 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2020

Last Update Posted Date

Jul 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yoni Gutkovich, deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa., Medical Corps, Israel Defense ForcePrincipal Investigator

Lead Sponsor

Medical Corps, Israel Defense ForceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Meclizine responders	Active Comparator		Drug: Meclizine Hydrochloride
Meclizine non responders	Active Comparator		Drug: Meclizine Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meclizine Hydrochloride	Drug	Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meclizine plasma levels	ng/dl	2 hours after meclizine administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoni Evgeni Gutkovich, M.D/Ph.D	Contact	+972526894497		gutkovichj@gmail.com
Dror Tal, Ph.D	Contact	+972549096080		tldror1@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21163711	Background	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.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001559	Benzhydryl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic