The IMP is to be used as an analgesic for the relief of acute pain. MedDRA version: 12.0 Level: LLT Classification code 10002182 Term: Analgesia
Conditions
Sponsors
Wockhardt UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged from 1 – =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of airway/respiratory problems. 2. Evidence or history of epistaxis. 3. Known allergy to opiate medication or any excipients of the nasal spray (benzalkonium chloride and disodium edetate [ethylenediaminetetraacetic acid (EDTA)]). 4. Exposure to opiate analgesia in the preceding 7 days. 5. Exposure to drugs known to pharmacokinetically interact with diamorphine in the preceding 7 days. 6. Receiving any chronic medication, except inhaled asthma therapies. Patients that have received periodic simple analgesics such as paracetamol, ibuprofen etc will not be excluded. 7. Head injury or neurological problem. 8. Treatment with monoamine oxidase inhibitors in the previous 14 days. 9. Participation in a clinical study in the previous 30 days. 10. Patient trauma requiring cardiovascular resuscitation. 11. Females who are pregnant, lactating or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the single dose pharmacokinetic profile of intranasally administered diamorphine in children aged 1-<16 years.;Primary end point(s): - Pharmacokinetic parameters: (Metabolites: Acetylmorphine, Morphine, Morphine-3-glucuronide, Morphine-6-glucuronide) Pharmacodynamic parameters: • Post operative pain scores • Respiratory rate • Pulse rate • Oxygen saturation • Temperature Safety parameters: - Adverse event monitoring - Local tolerability (nasal irritation);Secondary Objective: • To obtain pharmacodynamic endpoints (post operative pain scores, pupil dilation, respiratory rate, pulse rate, oxygen saturation and temperature) • To investigate the relationship between the pharmacokinetics of intranasal diamorphine and pharmacodynamic endpoints. • To provide additional safety information (particularly nasal irritation effects) to the current profile for intranasal diamorphine in a hospital clinic day surgery setting in children. | — |
Countries
United Kingdom
Outcome results
None listed