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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Faculdade de Medicina do ABC.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT00525967
First received: September 5, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Cancer
Pain
Palliative Care
Drug: Methadone plus Acetaminophen or Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain: A Randomized, Double-Blind Study

Resource links provided by NLM:


Further study details as provided by Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • Pain intensity and time to equianalgesic effect [ Time Frame: within the first 7 days after switching ]

Secondary Outcome Measures:
  • Degree of nausea, vomiting, obstipation, xerostomia and drowsiness [ Time Frame: within the first 7 days of switching ]

Estimated Enrollment: 50
Study Start Date: February 2006
Estimated Study Completion Date: October 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525967

Contacts
Contact: Daniel IG Cubero, MD 55-11-81799103 danielcubero@uol.com.br

Locations
Brazil
Disciplina de Oncologia, Faculdade de Medicina do ABC Recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Auro del Giglio, Professor    55-11-49935491    sandrabr@netpoint.com.br   
Principal Investigator: Daniel IG Cubero, MD         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00525967     History of Changes
Other Study ID Numbers: 217/2005
Study First Received: September 5, 2007
Last Updated: September 5, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Medicina do ABC:
Cancer Pain
Methadone
Morphine
Acetaminophen
Palliative Care

Additional relevant MeSH terms:
Methadone
Acetaminophen
Morphine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 14, 2014