NCT03324815

Brief Summary

The study was prospective, randomized. Patients with cancer pain were evaluated, one group receiving methadone with morphine and another group receiving morphine as the only opioid. Pain intensity, total morphine dose and adverse effects were evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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 2, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

October 25, 2017

Last Update Submit

October 26, 2017

Conditions

Cancer

Keywords

MorphineMethadonePain

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Total dose of morphine used by the patient

    3 months

Secondary Outcomes (1)

  • Pain intensity

    3 months

Study Arms (2)

Morphine- Methadone

ACTIVE COMPARATOR

Morphine 5mg/6h plus metadone: 2,5mg/12h

Drug: MorphineDrug: Methadone

Morphine

ACTIVE COMPARATOR

Morphine: 5mg/6h

Drug: Morphine

Interventions

MorphineDRUG

Pain Treatment

Also known as: Dimorf
MorphineMorphine- Methadone
MethadoneDRUG

Pain Treatment

Also known as: Mytedom
Morphine- Methadone

Eligibility Criteria

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

You may qualify if:

  • Approved by the Ethics Committee
  • signed the informed consent
  • cancer pain
  • starting the WHO thirth analgesic ladder,

You may not qualify if:

  • cognitive impairment
  • psychiatric disease
  • illicit drug user
  • hypersensitivity to the study drugs
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rioko K Sakata

São Paulo, Brazil

RECRUITING

Related Publications (1)

  • Duarte FCN, Ferraro LHDC, Ferreira A, Sakata RK. A Randomized Controlled Trial Evaluating the Analgesic Effect of the Combination of Methadone With Morphine for Cancer Related Pain. Clin J Pain. 2021 Sep 1;37(9):664-668. doi: 10.1097/AJP.0000000000000959.

    PMID: 34265791DERIVED

MeSH Terms

Conditions

NeoplasmsPain

Interventions

MorphineMethadone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsKetonesOrganic Chemicals

Study Officials

  • Rioko K Sakata, MD; PhD

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feliciano NC Duarte, MD

CONTACT

55 11 99265 7272feliciano.contardo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2017

First Posted

October 30, 2017

Study Start

March 2, 2017

Primary Completion

July 30, 2018

Study Completion

August 30, 2018

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

BR(1)