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 )

First Received on February 20, 2008. Last Updated on March 8, 2010 History of Changes

Sponsor:	Mundipharma Research Limited
Information provided by:	Mundipharma Research Limited
ClinicalTrials.gov Identifier:	NCT00626600

Purpose

Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.

Condition	Intervention	Phase
Severe Caner Pain	Drug: Oxycodone Hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:

To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL

Enrollment:	33
Study Start Date:	May 2008
Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626600

Locations

United Kingdom
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ

Sponsors and Collaborators

Mundipharma Research Limited

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00626600 History of Changes
Other Study ID Numbers:	OXI3001, 2007-005101-21
Study First Received:	February 20, 2008
Last Updated:	March 8, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Mundipharma Research Limited:

Oxycodone Hydrochloride 50mg/mL
Observational
Infusion
Severe cancer pain

Additional relevant MeSH terms:

Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 12, 2012