Therapeutic Drug Monitoring of Anxiolytics in Children | NCT03960671

Studies
Therapeutic Drug Monitoring of Anxiolytics in Children

NCT03960671

Sponsor

Wei Zhao

Status

Unknown status

Last Update Posted

May 23, 2019Actual

Enrollment

500Estimated

Phase

Phase 4

Conditions

Anxiolytics

Interventions

Midazolam/diazepam/propofol

Countries

China

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

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Apr 27, 2019

First Submission Date that Met QC Criteria

May 21, 2019

First Posted Date

May 23, 2019Actual

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

May 21, 2019

Last Update Posted Date

May 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Zhao, Professor; Head of department of clinical pharmacy and pharmacology, Shandong UniversitySponsor-Investigator

Lead Sponsor

Wei ZhaoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the therapeutic drug monitoring of anxiolytics is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then the investigators analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of anxiolytics in Chinese children.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anxiolytics	Experimental	Pediatric patients treated with sedation using anxiolytics	Drug: Midazolam/diazepam/propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Midazolam/diazepam/propofol	Drug	Therapeutic drug monitoring of anxiolytics	Anxiolytics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma drug concentration	To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).	Through study completion, an average of 14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anxiolytics was used for therapeutic purposes;
Age:≤18 years;
Patients with therapeutic concentration monitoring of anxiolytics.

Exclusion Criteria:

Patients without therapeutic concentration monitoring of anxiolytics;
The blood concentrations of the patient was not approved by the quality control center
Use foods or products that inhibit or induce CYP 3A activity.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

29 Days

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhao Wei, Ph.D	Contact	86053188383308		zhao4wei2@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shandong Provincial Qianfoshan Hospital	Recruiting	Ji'nan	Shandong	250014	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided