A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00626600
Recruitment Status :
(Lack of recruitment)
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.
Condition or disease
Severe Caner Pain
Drug: Oxycodone Hydrochloride
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female subjects aged 18 years and above, who have severe cancer pain.
Subjects who require a strong opioid by subcutaneous infusion to stabilise and manage their cancer pain effectively.
Subjects who give written informed consent to participate in the study.
Subjects who agree to their primary care physician being informed of their participation in the study.
Subjects who consent to processing of their trial data according to the requirements of the UK Data Protection Act 1998.
Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving and are not using adequate contraception measures.
Subjects with known hypersensitivity (allergic reaction) to oxycodone, any other opioids or any of the excipients.
Subjects who are planned to receive chemotherapy during the study treatment period or are currently receiving continuous i.v. chemotherapy infusion.
Subjects with neutropenia, thrombocytopenia or coagulation disorders.
Subjects with any contraindications to oxycodone as outlined in the Investigator Brochure or Summary Product Information sheet for oxycodone.
Subjects who are currently participating in another clinical research study involving a new chemical entity.
Subjects whom the Investigator believes to be medically unfit to receive the study medication, or unsuitable for any other reason.