AnxiolyticsPhase 4NCT03960671
Therapeutic Drug Monitoring of Anxiolytics in Children
A Phase 4 study testing Midazolam/diazepam/propofol in people with Anxiolytics, run by Wei Zhao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Anxiolytics
- What is being tested?
- Midazolam/diazepam/propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Anxiolytics was used for therapeutic purposes;
- Age:≤18 years;
- Patients with therapeutic concentration monitoring of anxiolytics.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Qianfoshan Hospital
Ji'nan, Shandong, 250014
Zhao Wei, Ph.D., 86053188383308, zhao4wei2@hotmail.com
About this study
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.
- Conditions
- Anxiolytics
- Being tested
- Midazolam/diazepam/propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam/diazepam/propofolDrug
Therapeutic drug monitoring of anxiolytics
| Study group | Role | What they receive |
|---|---|---|
| Anxiolytics | Experimental | Pediatric patients treated with sedation using anxiolytics Receives: Drug: Midazolam/diazepam/propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentration
To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Aug 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxiolyticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960671
- Sponsor's protocol ID
- 2019-anxiolytics-001
- Status last verified
- May 2019
- First submitted
- 27 Apr 2019
- Last updated
- 23 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Anxiolytics in Children
- ClinicalTrials.gov ID
- NCT03960671
- Acronym / sponsor ID
- 2019-anxiolytics-001
- Conditions
- Anxiolytics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wei ZhaoUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anxiolytics | Experimental | Drug: Midazolam/diazepam/propofolPediatric patients treated with sedation using anxiolytics |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Anxiolytics was used for therapeutic purposes;
- Age:≤18 years;
- Patients with therapeutic concentration monitoring of anxiolytics.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam/diazepam/propofolTherapeutic drug monitoring of anxiolytics | Drug | Anxiolytics |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam/diazepam/propofol in people with Anxiolytics, run by Wei Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Wei, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma drug concentration (time frame: Through study completion, an average of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.