An Open, Multi-centre, Non-comparative Observational Study to Assess the Safety and Tolerability of Oxycodone Injection 50 mg/mL as a Subcutaneous Infusion in Patients With Severe Cancer Pain.
This is study involving a treatment phase of up to 20 days. During this time patients will
receive Oxycodone Hydrochloride 50mg/ml as a subcutaneous infusion. During the treatment
phase, safety will be assessed by documentation of type and frequency of spontaneously
reported adverse events and adverse events noted after assessment of the infusion site
(every 24 hours and when resited). The subjects will be followed up for 7 days to collect
information on ongoing AEs/SAEs and any new AEs/SAEs that may have occurred.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
United Kingdom: Medicines and Healthcare Products Regulatory Agency