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Clinical Trials/NCT03960671
NCT03960671
Unknown
Phase 4

Therapeutic Drug Monitoring of Anxiolytics in Children

Wei Zhao1 site in 1 country500 target enrollmentAugust 1, 2018

Overview

Phase
Phase 4
Intervention
Midazolam/diazepam/propofol
Conditions
Anxiolytics
Sponsor
Wei Zhao
Enrollment
500
Locations
1
Primary Endpoint
Plasma drug concentration
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
December 31, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Wei Zhao
Responsible Party
Sponsor Investigator
Principal Investigator

Wei Zhao

Professor; Head of department of clinical pharmacy and pharmacology

Shandong University

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.

Arms & Interventions

Anxiolytics

Pediatric patients treated with sedation using anxiolytics

Intervention: Midazolam/diazepam/propofol

Outcomes

Primary Outcomes

Plasma drug concentration

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

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

Study Sites (1)

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