COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626600
Recruitment Status : Terminated (Lack of recruitment)
First Posted : February 29, 2008
Last Update Posted : October 24, 2018
Information provided by (Responsible Party):
Mundipharma Research Limited

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

Condition or disease Intervention/treatment Phase
Severe Caner Pain Drug: Oxycodone Hydrochloride Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL [ Time Frame: 20 Days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626600

Layout table for location information
United Kingdom
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Mundipharma Research Limited
Additional Information:
Layout table for additonal information
Responsible Party: Mundipharma Research Limited Identifier: NCT00626600    
Other Study ID Numbers: OXI3001
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Keywords provided by Mundipharma Research Limited:
Oxycodone Hydrochloride 50mg/mL
Severe cancer pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Cancer Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents