A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
This study has been terminated.
(Lack of recruitment)
Information provided by (Responsible Party):
Mundipharma Research Limited
First received: February 20, 2008
Last updated: October 25, 2012
Last verified: October 2012
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.
Severe Caner Pain
Drug: Oxycodone Hydrochloride
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open, Multi-centre, Non-comparative Observational Study to Assess the Safety and Tolerability of Oxycodone Injection 50 mg/mL as a Subcutaneous Infusion in Patients With Severe Cancer Pain.
Primary Outcome Measures:
- To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL [ Time Frame: 20 Days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2009 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626600
|Royal Marsden Hospital
|London, United Kingdom, SW3 6JJ |
Mundipharma Research Limited
No publications provided
||Mundipharma Research Limited
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 20, 2008
||October 25, 2012
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Mundipharma Research Limited:
Oxycodone Hydrochloride 50mg/mL
Severe cancer pain
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents