Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study
1 other identifier
interventional
42
1 country
1
Brief Summary
Cancer patients on morphine for chronic pain, with side effects or unsatisfactory pain relief, will be rotated to Methadone. We will try to find out what is the best methode to rotate, and the equivalent dosage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 cancer
Started Aug 2004
Typical duration for phase_3 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFebruary 28, 2014
February 1, 2014
5.1 years
September 15, 2005
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The overall aim of the present study is to validate the switching procedure from morphine to methadone for patients with advanced cancer and a short life expectancy. More specifically, we will:
2 weeks
Secondary Outcomes (2)
Collect blood samples for present and future genetic analyses in order to explore inter individual variations in methadone and morphine doses based upon possible polymorphisms.
2 weeks
Compare the QT-intervals on electrocardiograms obtained before and after start with methadone.
2 weeks
Study Arms (2)
methadon
ACTIVE COMPARATORMorphine methadone stop and go switch
Methadone
ACTIVE COMPARATORMethadon morphine overlap switch
Interventions
To methods for switching morphine to methadon. Stop-and go versus overlap
Eligibility Criteria
You may qualify if:
- Malignant disease.
- On morphine and in need of opioid rotation. (A patient in need of opioid rotation is defined as having insufficient pain control with or without unacceptable side effects from opioids).
- Able to complete the planned assessment schedules.
- Above 18 years of age.
- If out-patient, the patient lives with someone who can observe him/her.
- Given informed consent according to the ethical guidelines.
You may not qualify if:
- Not able to read or write in Norwegian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Olavs Hospital
Trondheim, Trondheim, 7006, Norway
Related Publications (1)
Moksnes K, Dale O, Rosland JH, Paulsen O, Klepstad P, Kaasa S. How to switch from morphine or oxycodone to methadone in cancer patients? a randomised clinical phase II trial. Eur J Cancer. 2011 Nov;47(16):2463-70. doi: 10.1016/j.ejca.2011.06.047. Epub 2011 Jul 19.
PMID: 21775131RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stein Kaasa, MD,PhD Prof.
St Olavs University Hospital, Trondheim
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 16, 2005
Study Start
August 1, 2004
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
February 28, 2014
Record last verified: 2014-02