Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00142519

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Methadone Drug: methadone and morphine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Translational Studies in Analgesic Pharmacology: Analgesic Synergy in Clinical Pain. A Phase 2 Study Comparing a Single Dose of a 1:1 Combination of Methadone and Morphine With Morphine Alone in Patients With Post-operative Pain.

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

The primary goal of this 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. [ Time Frame: Time to the third request for the pain medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if there are any side effects from the combination of morphine and methadone when given together. [ Time Frame: assessed every 10 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	March 2005
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator methadone	Drug: Methadone Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
2: Experimental methadone and morphine	Drug: methadone and morphine Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg

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 1:1 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Retroperitoneal lymph node dissection
Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes
18 years of age or older
English-speaking
Give informed consent to participate in this study

Exclusion Criteria:

Known hypersensitivity to methadone or morphine
Patients with past or present history of substance abuse
Patients with a history of methadone treatment
Patients with a history of chronic pain requiring daily analgesic use for more than 3 months
Patients treated with opioids within one month from the scheduled surgery
Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).
Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142519

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Natalia Moryl, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan Kettering Cancer Center ( Natalie Moryl, MD )
Study ID Numbers:	05-025
Study First Received:	August 31, 2005
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00142519 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Pain
Analgesics
Retroperitoneal lymph node dissection

Additional relevant MeSH terms:

Respiratory System Agents
Morphine
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Methadone
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid
Pain, Postoperative

ClinicalTrials.gov processed this record on February 08, 2010