Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184496
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2005-09-15
Brief Title:
Switching From Morphine to Methadone A Clinical Pharmacological and Pharmacogenetic Study
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Switching From Morphine to Methadone A Clinical Pharmacological and Pharmacogenetic Study
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None