MidazolamMIDAZOLAMNCT03639428
Pharmacokinetic Evaluation of MDZ028
An observational study of Midazolam, run by Centre Hospitalier Universitaire, Amiens.
Trial summary
Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Midazolam
- What is being tested?
- Midazolam
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2011to 30 Nov 2017
- Phase
- Observational
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The planned enrollment is 36 children, stratified in two groups: 24 children between 6 months and 11 years, and 12 children between 12 and 17 years. Age is considered in years past by the date of inclusion. Children aged between 6 months and 11 years old should be homogenous in both age groups 6-23 months and 2-11 years. For example, at least 4 children in the 6-23 month age group will be recruited. Children likely to be included will be hospitalized in the pediatric surgery department at Amiens University Hospital. Children who will be included in this study will not be able to participate in another study within 3 months of their inclusion in this study.
Who may be able to join
- Child (boy or girl) for whom surgery under general anesthesia is scheduled.
- Child aged 6 months to 17 years old.
- Child with a body mass index between the 3rd and 97th percentile.
- Child with ASA (American Society of Anesthesiology) status of I or II. Young girl of childbearing age (ie after puberty) and sexually active to have a result negative to the pregnancy test.
- Child whose parents / legal representative (s) agree to sign a consent form.
- Child whose opinion / agreement was / tried to be collected.
- Child and parents / legal representative (s) being ready and able to participate in the study, understanding and undertaking to respect the study procedures throughout the duration of the study.
- Child enrolled in a social security scheme.
Who cannot join
- Child with midazolam allergy, benzodiazepine hypersensitivity or hypersensitivity known to one of the excipients of the formulation of the study.
- Child with respiratory disease (severe respiratory failure, acute respiratory depression).
- Child with heart disease.
- Child with gastrointestinal disorders that may affect absorption or gastroesophageal reflux.
- Child with growth disorders or abnormal weight-of-weight.
- Child taking Cytochrome P450 Interactions Within 60 Days of Inclusion in the study.
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- Child with kidney failure, liver failure, history of myasthenia gravis, or neurological disease.
- Pregnant or lactating girl.
- Child who has a known human immunodeficiency virus (HIV) infection, or active hepatitis B, or active hepatitis C.
- A child who could present any condition that may prevent his participation in the study, according to the judgment of the investigator.
About this study
Official title: Pharmacokinetic Evaluation of MDZ028 After Single Administration of a New Oral Form, at the Time of Anesthetic Premedication in Children.
Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling.
Read the detailed description
In the absence of a licensed formulation in many countries worldwide, ADV6209, an innovative 2mg/ml oral solution of midazolam containing cyclodextrin, has been developed for moderate sedation in paediatric patients. Population pharmacokinetics for ADV6209 is reported.
Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling. Plasma concentrations of midazolam were discribed by a two-compartement model. An additional one-compartement model was added for a α-hydroxymidazolam.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called midazolam dose of ADV6209
All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209
| Study group | Role | What they receive |
|---|---|---|
| 6 - 23 months | 8 infants between 6 and 23 months received a single 0.3mg/kg midazolam dose of ADV6209 Receives: Drug: Midazolam | |
| 2-11 years | 17 children between 2 and 11 years received a single 0.3mg/kg midazolam dose of ADV6209 Receives: Drug: Midazolam | |
| 12-17 years | 12 adolescents between 12 and 17 years received a single 0.3mg/kg midazolam dose of ADV6209 Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic analysis of the oral solution of midazolam (ADV6209)
The Aim of the study was to assess the pharmacokinetic analysis of an oral solution of midazolam (ADV6209) oral formulation in paedriatic patients from 6 months to 18 years ols in order to support dosing recommendations. All subjects received a single 0.3mg/kg midazolam dose of ADV6209, without exceeding a total dose of 10 mg.Population pharmacokinetic modelling was performed to characterise the concentration-time course of midazolam and its main active metabolite, and to evaluate the changes in clearance and volume of distibution in the different age groups.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start23 Jun 2011
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MidazolamStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé DUPONT, PU-PH, Principal investigator, CHU AMIENS-PICARDIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639428
- Sponsor's protocol ID
- PI10-PR-DUPONT
- Acronym
- MIDAZOLAM
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2018
- Last updated
- 15 Jun 2026
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of MDZ028 After Single Administration of a New Oral Form, at the Time of Anesthetic Premedication in Children.
- ClinicalTrials.gov ID
- NCT03639428
- Acronym / sponsor ID
- MIDAZOLAM / PI10-PR-DUPONT
- Conditions
- Midazolam
- Keywords
- pharmacokinetics, child, cyclodextrin, moderate sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 23 Jun 2011 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 21 Aug 2018 (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.
Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling.
Detailed description
In the absence of a licensed formulation in many countries worldwide, ADV6209, an innovative 2mg/ml oral solution of midazolam containing cyclodextrin, has been developed for moderate sedation in paediatric patients. Population pharmacokinetics for ADV6209 is reported.
Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose, randomised, open-label two-peiod crossover bioavailability study, respectively. Data were analysed using non-linear mixed effect modeling. Plasma concentrations of midazolam were discribed by a two-compartement model. An additional one-compartement model was added for a α-hydroxymidazolam.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 - 23 months | – | Drug: Midazolam8 infants between 6 and 23 months received a single 0.3mg/kg midazolam dose of ADV6209 |
| 2-11 years | – | Drug: Midazolam17 children between 2 and 11 years received a single 0.3mg/kg midazolam dose of ADV6209 |
| 12-17 years | – | Drug: Midazolam12 adolescents between 12 and 17 years received a single 0.3mg/kg midazolam dose of ADV6209 |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The planned enrollment is 36 children, stratified in two groups: 24 children between 6 months and 11 years, and 12 children between 12 and 17 years. Age is considered in years past by the date of inclusion. Children aged between 6 months and 11 years old should be homogenous in both age groups 6-23 months and 2-11 years. For example, at least 4 children in the 6-23 month age group will be recruited. Children likely to be included will be hospitalized in the pediatric surgery department at Amiens University Hospital. Children who will be included in this study will not be able to participate in another study within 3 months of their inclusion in this study.
Key inclusion criteria (8 listed)
- Child (boy or girl) for whom surgery under general anesthesia is scheduled.
- Child aged 6 months to 17 years old.
- Child with a body mass index between the 3rd and 97th percentile.
- Child with ASA (American Society of Anesthesiology) status of I or II. Young girl of childbearing age (ie after puberty) and sexually active to have a result negative to the pregnancy test.
- Child whose parents / legal representative (s) agree to sign a consent form.
Key exclusion criteria (10 listed)
- Child with midazolam allergy, benzodiazepine hypersensitivity or hypersensitivity known to one of the excipients of the formulation of the study.
- Child with respiratory disease (severe respiratory failure, acute respiratory depression).
- Child with heart disease.
- Child with gastrointestinal disorders that may affect absorption or gastroesophageal reflux.
- Child with growth disorders or abnormal weight-of-weight.
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 |
|---|---|---|
| MidazolamAlso: midazolam dose of ADV6209All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209 | Drug | 12-17 years, 2-11 years, 6 - 23 months |
Primary outcome
Pharmacokinetic analysis of the oral solution of midazolam (ADV6209)
Time frame: 1 day
The Aim of the study was to assess the pharmacokinetic analysis of an oral solution of midazolam (ADV6209) oral formulation in paedriatic patients from 6 months to 18 years ols in order to support dosing recommendations. All subjects received a single 0.3mg/kg midazolam dose of ADV6209, without exceeding a total dose of 10 mg.Population pharmacokinetic modelling was performed to characterise the concentration-time course of midazolam and its main active metabolite, and to evaluate the changes in clearance and volume of distibution in the different age groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- 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.
Hervé DUPONT, PU-PH principal investigator
CHU AMIENS-PICARDIE
Questions about this trial
What is this clinical trial studying?
An observational study of Midazolam, run by Centre Hospitalier Universitaire, Amiens.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic analysis of the oral solution of midazolam (ADV6209) (time frame: 1 day). 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 15 Jun 2026.