Status:
TERMINATED
A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
Lead Sponsor:
Mundipharma Research Limited
Conditions:
Severe Caner Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00626600
Start Date
May 1 2008
End Date
June 1 2009
Last Update
October 24 2018
Active Locations (1)
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1
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ