ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: morphine Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability and Effectiveness of Transdermally Administered Morphine
Study Start Date : July 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. detectable morphine levels in serum


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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00125684


Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Tom Baker Cancer Centre
Investigators
Principal Investigator: Neil Hagen Alberta Cancerboard

Responsible Party: Rachel Syme, Dr. Neil Hagen - Principal Investigator, Alberta Health Services
ClinicalTrials.gov Identifier: NCT00125684     History of Changes
Other Study ID Numbers: 10181
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: August 2011

Keywords provided by Rachel Syme, Alberta Health Services:
transdermal morphine
cancer
pain
bioavailability
pharmacokinetics
cancer related pain
stable baseline pain
currently taking opioids

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