Bioavailability and Effectiveness of Transdermally Administered Morphine

This study has been completed.
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
Rachel Syme, Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00125684
First received: July 29, 2005
Last updated: January 18, 2012
Last verified: August 2011
  Purpose

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 Intervention Phase
Cancer
Pain
Drug: morphine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioavailability and Effectiveness of Transdermally Administered Morphine

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • detectable morphine levels in serum

Estimated Enrollment: 6
Study Start Date: July 2003
Study Completion Date: July 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125684

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
AHS Cancer Control Alberta
Tom Baker Cancer Centre
Investigators
Principal Investigator: Neil Hagen Alberta Cancerboard
  More Information

No publications provided

Responsible Party: Rachel Syme, Dr. Neil Hagen - Principal Investigator, Alberta Health Services
ClinicalTrials.gov Identifier: NCT00125684     History of Changes
Other Study ID Numbers: 10181
Study First Received: July 29, 2005
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
transdermal morphine
cancer
pain
bioavailability
pharmacokinetics
cancer related pain
stable baseline pain
currently taking opioids

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

ClinicalTrials.gov processed this record on April 17, 2014