Severe cancer pain
Conditions
Interventions
Product Name: Oxycodone hydrochloride injection 50 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Oxycodone hydrochloride
CAS Number: 51481-60-8
Other descriptive name: 4,5-a-Ep
Sponsors
Mundipharma Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 years and over, who have severe cancer pain. 2. Subjects who require a strong opioid by subcutaneous infusion to stabilise and manage their cancer pain effectively. 3. Subjects who have provided written informed consent. 4. Subjects who agree to their general practitioner being informed of their participation in the study. 5. Subjects who consent to processing of their study data according to the requirements of the UK Data Protection Act 1998. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant, lactating or in the investigators opinion are at risk of conceiving and are not using adequate contraception measures. 2. Subjects with known hypersensitivity (allergic reaction) to oxycodone, any other opioids or any of the excipients. 3. Subjects who are planned to receive chemotherapy during the study treatment period or are currently receiving continuous i.v. chemotherapy infusion. 4. Subjects with neutropenia, thrombocytopenia or coagulation disorders 5. Subjects with any contraindications to oxycodone as outlined in the Investigator Brochure or Summary Product Information sheet for oxycodone. 6. Subjects who are currently participating in another clinical research study involving a new chemical entity. 7. Subjects whom the investigator believes to be medically unfit to receive the study medication, or unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL, solution for injection or infusion administered as a subcutaneous infusion in subjects with severe cancer pain.;Secondary Objective: ;Primary end point(s): Safety will be assessed by documentation of frequency and kind of spontaneously reported adverse events and adverse events recorded after assessment of the infusion site. Vital signs will be carried out pre-treatment and at the end of the treatment. | — |
Countries
United Kingdom
Outcome results
None listed