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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00525967
Enrollment
50
Registered
2007-09-06
Start date
2006-02-28
Completion date
2007-10-31
Last updated
2007-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pain, Palliative Care

Keywords

Cancer Pain, Methadone, Morphine, Acetaminophen, Palliative Care

Brief summary

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

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.

Interventions

DRUGMethadone plus Acetaminophen or Placebo

Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid

Sponsors

Faculdade de Medicina do ABC
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain intensity and time to equianalgesic effectwithin the first 7 days after switching

Secondary

MeasureTime frame
Degree of nausea, vomiting, obstipation, xerostomia and drowsinesswithin the first 7 days of switching

Countries

Brazil

Contacts

Primary ContactDaniel IG Cubero, MD
danielcubero@uol.com.br55-11-81799103

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026