NCT03960671

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

4.4 years

First QC Date

April 27, 2019

Last Update Submit

May 21, 2019

Conditions

Anxiolytics

Outcome Measures

Primary Outcomes (1)

  • Plasma drug concentration

    To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).

    Through study completion, an average of 14 days

Study Arms (1)

Anxiolytics

EXPERIMENTAL

Pediatric patients treated with sedation using anxiolytics

Drug: Midazolam/diazepam/propofol

Interventions

Midazolam/diazepam/propofolDRUG

Therapeutic drug monitoring of anxiolytics

Anxiolytics

Eligibility Criteria

Age29 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Ji'nan, Shandong, 250014, China

RECRUITING

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Zhao Wei, Ph.D

CONTACT

86053188383308zhao4wei2@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor; Head of department of clinical pharmacy and pharmacology

Study Record Dates

First Submitted

April 27, 2019

First Posted

May 23, 2019

Study Start

August 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)