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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00142519
First received: August 31, 2005
Last updated: August 14, 2014
Last verified: August 2014

August 31, 2005
August 14, 2014
March 2005
March 2015   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00142519 on ClinicalTrials.gov Archive Site
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 ]
To determine if there are any side effects from the combination of morphine and methadone when given together.
Not Provided
Not Provided
 
Comparison of A Single Dose Combination of Methadone and Morphine With Morphine Alone for Treating Post-operative Pain
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.

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Methadone
    Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg
  • 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
  • Active Comparator: 1
    methadone
    Intervention: Drug: Methadone
  • Experimental: 2
    methadone and morphine
    Intervention: Drug: methadone and morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00142519
05-025
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Natalia Moryl, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP