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Therapeutic Drug Monitoring of Anxiolytics in Children

Therapeutic Drug Monitoring of Anxiolytics in Children

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03960671
Enrollment
500
Registered
2019-05-23
Start date
2018-08-01
Completion date
2022-12-31
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiolytics

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.

Interventions

DRUGMidazolam/diazepam/propofol

Therapeutic drug monitoring of anxiolytics

Sponsors

Wei Zhao
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
29 Days to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma drug concentrationThrough study completion, an average of 14 daysTo detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).

Countries

China

Contacts

Primary ContactZhao Wei, Ph.D
zhao4wei2@hotmail.com86053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026