Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142519
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2005-08-31
Brief Title:
Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Translational Studies in Analgesic Pharmacology Analgesic Synergy in Clinical Pain A Phase 2 Study Comparing a Single Dose of a 11 Combination of Methadone and Morphine With Morphine Alone in Patients With Post-operative Pain
Status:
COMPLETED
Status Verified Date:
2018-08
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:
This is a randomized Phase II study testing the effectiveness of the combination of morphine and methadone versus morphine alone in relieving pain A second goal is to further evaluate any side effects of the combination of morphine and methadone
Detailed Description:
Rationale Experimental data demonstrates a profound analgesic synergy between morphine and methadone when co-administered systemically in mice If this type of synergy can be demonstrated in clinical pain it will be a relatively unique example of translating concepts of fundamental aspects of opioid actions seen in the laboratory to the clinical area and provide a basis for offering new and scientifically- based analgesic regimens This may provide better pain relief with less opioid related side effects in clinical practice
Purpose
This is a randomized double blind parallel arm Phase II study comparing a single dose of 11 combination of methadone and morphine with morphine alone in patients with post-operative pain
The primary objective of this randomized double blind parallel arm Phase II study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain
A second goal is to further evaluate any side effects of the combination of morphine and methadone
Purpose
This is a randomized double blind parallel arm Phase II study comparing a single dose of 11 combination of methadone and morphine with morphine alone in patients with post-operative pain
The primary objective of this randomized double blind parallel arm Phase II study is to compare the analgesic effects of a combination of morphine and methadone with morphine alone to determine synergistic activity of mu opioid analgesics in patients with post-operative pain
A second goal is to further evaluate any side effects of the combination of morphine and methadone
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