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)
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT00626600
First received: February 20, 2008
Last updated: October 25, 2012
Last verified: October 2012
  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 3

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:


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 [ Time Frame: 20 Days ] [ Designated as safety issue: No ]

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

  1. Male or female subjects aged 18 years and above, who have severe cancer pain.
  2. Subjects who require a strong opioid by subcutaneous infusion to stabilise and manage their cancer pain effectively.
  3. Subjects who give written informed consent to participate in the study.
  4. Subjects who agree to their primary care physician being informed of their participation in the study.
  5. Subjects who consent to processing of their trial data according to the requirements of the UK Data Protection Act 1998.

Exclusion Criteria

  1. Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving and are not using adequate contraception measures.
  2. Subjects with known hypersensitivity (allergic reaction) to oxycodone, any other opioids or any of the excipients.
  3. Subjects who are planned to receive chemotherapy during the study treatment period or are currently receiving continuous i.v. chemotherapy infusion.
  4. Subjects with neutropenia, thrombocytopenia or coagulation disorders.
  5. Subjects with any contraindications to oxycodone as outlined in the Investigator Brochure or Summary Product Information sheet for oxycodone.
  6. Subjects who are currently participating in another clinical research study involving a new chemical entity.
  7. Subjects whom the Investigator believes to be medically unfit to receive the study medication, or unsuitable for any other reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT00626600     History of Changes
Other Study ID Numbers: OXI3001, 2007-005101-21
Study First Received: February 20, 2008
Last Updated: October 25, 2012
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
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014