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Bioavailability and Effectiveness of Transdermally Administered Morphine

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: NCT00125684
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
Rachel Syme, Alberta Health Services

Tracking Information
First Submitted Date  ICMJE July 29, 2005
First Posted Date  ICMJE August 2, 2005
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE July 2003
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2005)
detectable morphine levels in serum
Original Primary Outcome Measures  ICMJE Same as current
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 Bioavailability and Effectiveness of Transdermally Administered Morphine
Official Title  ICMJE Bioavailability and Effectiveness of Transdermally Administered Morphine
Brief Summary Patients will participate in two arms of the trial, one in which morphine will be administered transdermally, and, after a 3 day wash out period, one in which morphine will be administered subcutaneously.
Detailed Description Patients will participate in two arms of the trial, one in which morphine will be administered transdermally, and, after a 3 day wash out period, one in which morphine will be administered subcutaneously. Blood draws will be done after both dosing methods in order to compare blood levels of morphine by the different routes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Pain
Intervention  ICMJE Drug: morphine
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 Completed
Estimated Enrollment  ICMJE
 (submitted: August 1, 2005)
6
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic cancer pain
  • Minimum baseline pain of 3/10
  • No change in medications over 3 days prior to study period
  • Ability to give informed consent
  • Willingness to undergo repeated blood sampling

Exclusion Criteria:

  • Use of morphine or codeine in 3 days prior to study
  • Known sensitivity to morphine
  • Prior anaphylactic reaction to any opioid
  • Clinically significant anemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00125684
Other Study ID Numbers  ICMJE 10181
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rachel Syme, Alberta Health Services
Study Sponsor  ICMJE Alberta Health Services
Collaborators  ICMJE Tom Baker Cancer Centre
Investigators  ICMJE
Principal Investigator: Neil Hagen Alberta Cancerboard
PRS Account AHS Cancer Control Alberta
Verification Date August 2011

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