Clinical Trial: Comparison of A Single Dose Combination of Methadone and Morphine with Morphine Alone for Treating Post-Operative Pain

This study is currently recruiting patients.
Verified by Memorial Sloan-Kettering Cancer Center August 2005

Sponsored by: 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: Morphine
 Drug: Methadone
Phase II

MedlinePlus related topics:  Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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.

Further Study Details: 
Primary Outcomes: 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.
Secondary Outcomes: To determine if there are any side effects from the combination of morphine and methadone when given together.
Expected Total Enrollment:  70

Study start: March 2005

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 above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00142519

Natalia Moryl, MD      212.639.8133    moryln@mskcc.org

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

Study chairs or principal investigators

Natalia Moryl, MD,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   

More Information

Study ID Numbers:  05-025
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142519
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06

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