Study Stopped
Lack of recruitment
A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
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.
2 other identifiers
interventional
33
1 country
1
Brief Summary
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 24, 2018
October 1, 2018
1 year
February 20, 2008
October 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
20 Days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 29, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
October 24, 2018
Record last verified: 2018-10