Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain

September 5, 2007 updated by: Faculdade de Medicina do ABC

Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain: A Randomized, Double-Blind Study

The purpose of this study is to determine whether oral methadone plus acetaminophen can substitute morphine in the treatment of cancer pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Opioids are the mainstay of moderate-to-severe cancer pain management. Although morphine is the most commonly used, methadone has some advantages such as higher potency, lower cost and longer administration intervals. To minimize the time necessary to achieve the equianalgesic effect after a switching from morphine to methadone, acetaminophen was added in the treatment.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-650
        • Recruiting
        • Disciplina de Oncologia, Faculdade de Medicina do ABC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of cancer pain
  • Regular use of oral Morphine

Exclusion Criteria:

  • Use of Acetaminophen in the last 48 hours
  • Renal or Hepatic failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Methadone plus Placebo
Drug: Methadone plus Acetaminophen or Placebo
Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid
EXPERIMENTAL: 2
Methadone plus Acetaminophen
Drug: Methadone plus Acetaminophen or Placebo
Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity and time to equianalgesic effect
Time Frame: within the first 7 days after switching
within the first 7 days after switching

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of nausea, vomiting, obstipation, xerostomia and drowsiness
Time Frame: within the first 7 days of switching
within the first 7 days of switching

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Medicina do ABC

Investigators

  • Principal Investigator: Daniel IG Cubero, Faculdade de Medicina do ABC
  • Study Director: Auro del Giglio, Faculdade de Medicina do ABC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (ANTICIPATED)

October 1, 2007

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (ESTIMATE)

September 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 6, 2007

Last Update Submitted That Met QC Criteria

September 5, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217/2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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