NCT00142519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

August 1, 2018

Enrollment Period

13.3 years

First QC Date

August 31, 2005

Results QC Date

February 18, 2019

Last Update Submit

March 14, 2019

Conditions

Pain

Keywords

PainAnalgesicsRetroperitoneal lymph node dissection

Outcome Measures

Primary Outcomes (1)

  • 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 to the third request for the pain medication

Secondary Outcomes (1)

  • To Determine if There Are Any Side Effects From the Combination of Morphine and Methadone When Given Together.

    assessed every 10 minutes

Study Arms (2)

1

ACTIVE COMPARATOR

methadone

Drug: Methadone

2

EXPERIMENTAL

methadone and morphine

Drug: methadone and morphine

Interventions

MethadoneDRUG

Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg

1
methadone and morphineDRUG

Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

MethadoneMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Natalia Moryl, MD
Organization
Memorial Sloan Kettering Cancer Center
moryln@mskcc.org
646-888-2681

Study Officials

  • Natalia Moryl, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

March 1, 2005

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

March 15, 2019

Results First Posted

March 15, 2019

Record last verified: 2018-08

Locations

US(1)