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

Mundipharma

Status and phase: Terminated; Phase 3

Conditions: Severe Caner Pain

Treatments: Drug: Oxycodone Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626600

OXI3001

2007-005101-21

Details and patient eligibility

About

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

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)