An open, multi-centre, non-comparative observational study to assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL as a subcutaneous infusion in subjects with severe cancer pain.
- Conditions
- Severe cancer pain
- Registration Number
- EUCTR2007-005101-21-GB
- Lead Sponsor
- Mundipharma Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method