Bioavailability and Effectiveness of Transdermally Administered Morphine

This study has been completed.

First Received on July 29, 2005. Last Updated on January 18, 2012 History of Changes

Sponsor:	Alberta Health Services
Collaborator:	Tom Baker Cancer Centre
Information provided by (Responsible Party):	Rachel Syme, Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00125684

Purpose

Condition	Intervention	Phase
Cancer Pain	Drug: morphine	Phase I

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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

Alberta Health Services

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 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
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 February 12, 2012