E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In the context of the trial, the IMP is to be used as anaesthetic premedication in children undergoing elective routine surgery.
(The medical condition for marketing is acute seizures in children aged 3 months - <18 years.) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058073 |
E.1.2 | Term | Anaesthetic premedication |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the single dose pharmacokinetic profile of buccally administered midazolam in children from 3 months – <18 years. |
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E.2.2 | Secondary objectives of the trial |
To provide additional safety information (particularly buccal tolerability) to the current profile for buccal midazolam use. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female aged from 3 months – <18years of age. 2. Attending the hospital for routine elective surgery 3. In the clinical opinion of the clinician in charge, the child requires midazolam for pre-medication treatment. 4. Parent(s) or legal guardian in attendance. 5. Parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study. 6. Where applicable, the child should assent to undergo blood sampling for pharmacokinetic purposes and to allow physiological measurements to be made. 7. American Society of Anesthesiologists (ASA) classification of illness score of 2 or less
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E.4 | Principal exclusion criteria |
1. Known allergy to benzodiazepine medications. 2. Exposure to benzodiazepines (including midazolam) in the preceding 7 days. 3. Exposure to drugs known to pharmacokinetically interact with midazolam in the preceding 7 days. 4. Receiving any chronic medication, except inhaled asthma therapies. Patients that have received periodic simple analgesics such as paracetamol, ibuprofen etc will not be excluded. 5. Participation in this or any clinical study in the previous 30 days or scheduled to receive any other investigational drug during the course of the study. 6. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study. 7. Females who are pregnant, lactating or planning to become pregnant. 8. Patients with a known history of epilepsy
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E.5 End points |
E.5.1 | Primary end point(s) |
- Pharmacokinetic parameters for midazolam and 1-hydroxy midazolam
- Safety parameters: - Adverse event monitoring - Respiratory depression: - Local tolerability:
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is defined as 7 days after the last child’s hospital discharge. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |