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.) MedDRA version: 9.1 Level: LLT Classification code 10058073 Term: Anaesthetic premedication
Conditions
Interventions
Product Name: Midazolam Hydrochloride Oromucosal Solution
Product Code: Buccal midazolam
Pharmaceutical Form: Oromucosal solution
INN or Proposed INN: Midazolam
CAS Number: 59467-70-8
Other descriptiv
Sponsors
Therakind Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged from 3 months – =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the single dose pharmacokinetic profile of buccally administered midazolam in children from 3 months – <18 years.;Secondary Objective: To provide additional safety information (particularly buccal tolerability) to the current profile for buccal midazolam use.;Primary end point(s): - Pharmacokinetic parameters for midazolam and 1-hydroxy midazolam - Safety parameters: - Adverse event monitoring - Respiratory depression: - Local tolerability: | — |
Countries
Germany
Outcome results
None listed