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

This study is not yet open for participant recruitment.
Verified by Mundipharma Research Limited, October 2007

Sponsored by: 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
Severe Caner Pain
Drug: Oxycodone Hydrochloride

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Oxycodone    Oxycodone hydrochloride   

U.S. FDA Resources

Study Type:   Observational
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.

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

Estimated Enrollment:   50
Study Start Date:   May 2008
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   December 2008 (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

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

Contacts
Contact: Jill Kiteley     info@contact-clinical-trials.com    
Contact: Maggie Wilson     info@contact-clinical-trials.com    

Sponsors and Collaborators
Mundipharma Research Limited
  More Information

Study ID Numbers:   2007-005101-21, OXI3001
First Received:   February 20, 2008
Last Updated:   April 22, 2008
ClinicalTrials.gov Identifier:   NCT00626600
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  

Study placed in the following topic categories:
Oxycodone
Pain

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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