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Status unknownNCT03960671Updated May 23, 2019

Therapeutic Drug Monitoring of Anxiolytics in Children

A Phase 4 interventional study of Midazolam/diazepam/propofol in Anxiolytics, sponsored by Wei Zhao. Status unknown at 1 site in China. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2019-05-23.

Sponsored by Wei Zhao · Phase 4, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Aug 2018, registered Apr 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
29 Days to 18 Years
Sex
All
01

Study 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.

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Conditions studied

  • Anxiolytics
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In context

Lead sponsor

Wei Zhao is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Anxiolytics

    Pediatric patients treated with sedation using anxiolytics

    Drug: Midazolam/diazepam/propofol

Interventions

06

What researchers measure

Primary outcomes

  1. Plasma drug concentration

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

    Time frame: Through study completion, an average of 14 days

07

Study locations

1 of 1 sites recruiting
  • Shandong Provincial Qianfoshan Hospital
    Ji'nan, Shandong 250014, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2018 (actual). Primary completion is estimated for Dec 2022, 52 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2019
First posted
May 23, 2019
StartActual
Aug 1, 2018
Primary completionEst.
Dec 31, 2022
CompletionEst.
Dec 31, 2022
Last update
May 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03960671
Lead sponsor
Wei Zhao
Responsible party
Wei Zhao (Professor; Head of department of clinical pharmacy and pharmacology, Shandong University) — Sponsor-investigator
First posted
May 23, 2019
Start date
Aug 1, 2018
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
May 23, 2019

Study contacts

Zhao Wei, Ph.D
Contact
zhao4wei2@hotmail.com
86053188383308

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Midazolam · Diazepam · Propofol

Other studies from this sponsor

Wei Zhao

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