A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
Primary Purpose
Severe Caner Pain
Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Oxycodone Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Severe Caner Pain focused on measuring Oxycodone Hydrochloride 50mg/mL, Observational, Infusion, Severe cancer pain
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Sites / Locations
- Royal Marsden Hospital
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
Secondary Outcome Measures
Full Information
NCT ID
NCT00626600
First Posted
February 20, 2008
Last Updated
October 22, 2018
Sponsor
Mundipharma Research Limited
1. Study Identification
Unique Protocol Identification Number
NCT00626600
Brief Title
A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research Limited
4. Oversight
5. Study Description
Brief Summary
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Caner Pain
Keywords
Oxycodone Hydrochloride 50mg/mL, Observational, Infusion, Severe cancer pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxycodone Hydrochloride
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
Time Frame
20 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Facility Information:
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXI3001
Description
Link to Results
Learn more about this trial
A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
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