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| Sponsor: | Norwegian University of Science and Technology |
|---|---|
| Information provided by: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00184496 |
Purpose
Cancerpatients 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 eqvivalent dosage.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: Methadone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Switching From Morphine to Methadone. A Clinical, Pharmacological and Pharmacogenetic Study |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
methadon: Active Comparator
Morphine metahadone stop and go switch
|
Drug: Methadone
To methods for switching morphien to methadon. Stop-and go versus overlap
|
|
Methadone: Active Comparator
Methadon morphine overlap switch
|
Drug: Methadone
To methods for switching morphien to methadon. Stop-and go versus overlap
|
This study is based on the clinical observation that patients who are not well controlled on morphine or oxycodone may benefit from switching to another opioid, in this case methadone. Although the mechanism for such switch is not completely understood, evidence indicates that opioids with different chemical structures have different characteristics, not least in relation to new knowledge about genetic variation in opioid receptors. Another challenge is that there is much uncertainty regarding equianalgesic dose ratios for morphine and methadone. It seems that the higher the morphine doses, the relatively lower methadone doses are needed to substitute morphine. Furthermore, there is uncertainty to which switching procedures one should use, the most common ones are "stop and go" and a three days switch. Finally, it is reported that methadone may increase the QT interval of the ECG, and thus increase the risk for the ventricular arrhythmia Torsade de pointe. The aim of this randomized, open label, multicenter study is primarily to compare the switching procedures, but it will also provide more knowledge about equianalgesic dose ratios, the effect of methadone on the QT interval, genetical factors that may characterize patients needing opioid switch as well as their response to it, and finally if pharmacokinetic factors plays a role.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• Malignant disease.
Exclusion Criteria:
Contacts and Locations| Norway | |
| St Olavs Hospital | Recruiting |
| Trondheim, Norway, 7006 | |
| Contact: Stein Kaasa, MD, PhD +47 73867251 stein.kaasa@ntnu.no | |
| Contact: Ola Dale, MD, PhD +47 73598849 ola.dale@ntnu.no | |
| Principal Investigator: | Stein Kaasa, MD,PhD Prof. | St Olavs University Hospital, Trondheim |
More Information
| Responsible Party: | Norwegian University of Science and Technology ( Paal Klepstad, Assosiate professor ) |
| Study ID Numbers: | OPI 03/008 |
| Study First Received: | September 15, 2005 |
| Last Updated: | September 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00184496 History of Changes |
| Health Authority: | Norway: Norwegian Social Science Data Services |
|
Analgesics, Opioid/pharmacokinetics Humans Methdaone/theraputic use Neoplasms/complications pain/drugtherapy |
|
Respiratory System Agents Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Methadone Sensory System Agents |
Therapeutic Uses Analgesics Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Analgesics, Opioid |