Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain
Information source: Faculdade de Medicina do ABC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Pain; Palliative Care
Intervention: Methadone plus Acetaminophen or Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Faculdade de Medicina do ABC Official(s) and/or principal investigator(s):
Daniel IG Cubero, Principal Investigator, Affiliation: Faculdade de Medicina do ABC
Auro del Giglio, Study Director, Affiliation: Faculdade de Medicina do ABC
Overall contact:
Daniel IG Cubero, MD, Phone: 55-11-81799103, Email: danielcubero@uol.com.br
Summary
The purpose of this study is to determine whether oral methadone plus acetaminophen can
substitute morphine in the treatment of cancer pain.
Clinical Details
Official title: Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain: A Randomized, Double-Blind Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Pain intensity and time to equianalgesic effect
Secondary outcome: Degree of nausea, vomiting, obstipation, xerostomia and drowsiness
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Daniel IG Cubero, MD, Phone: 55-11-81799103, Email: danielcubero@uol.com.br
Disciplina de Oncologia, Faculdade de Medicina do ABC, Santo André, São Paulo 09060-650, Brazil; Recruiting
Auro del Giglio, Professor, Phone: 55-11-49935491, Email: sandrabr@netpoint.com.br
Daniel IG Cubero, MD, Principal Investigator
Additional Information
Newsletter, March 2004
Starting date: February 2006
Last updated: September 5, 2007
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