Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 685 for:    OXYCODONE

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.
 
ClinicalTrials.gov Identifier: NCT00626600
Recruitment Status : Terminated (Lack of recruitment)
First Posted : February 29, 2008
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited

Tracking Information
First Submitted Date  ICMJE February 20, 2008
First Posted Date  ICMJE February 29, 2008
Last Update Posted Date October 24, 2018
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2012)
To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL [ Time Frame: 20 Days ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion
Official Title  ICMJE 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.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Caner Pain
Intervention  ICMJE Drug: Oxycodone Hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 8, 2010)
33
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2008)
50
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00626600
Other Study ID Numbers  ICMJE OXI3001
2007-005101-21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mundipharma Research Limited
Study Sponsor  ICMJE Mundipharma Research Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mundipharma Research Limited
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP