A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Research Limited
• Treatments: Oxycodone

Criteria

Inclusion Criteria

1. Male or female subjects aged 18 years and above, 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 give written informed consent to participate in the study.

4. Subjects who agree to their primary care physician being informed of their participation in the study.

5. Subjects who consent to processing of their trial data according to the requirements of the UK Data Protection Act 1998.

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.