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

Sponsor

Faculdade de Medicina do ABC (Other)

Overall Status

Unknown status

CT.gov ID

NCT00525967

Collaborator

(none)

Enrollment

Location

Arms

19.9

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Feb 1, 2006

Anticipated Study Completion Date :

Oct 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain intensity and time to equianalgesic effect [within the first 7 days after switching]

Secondary Outcome Measures

Degree of nausea, vomiting, obstipation, xerostomia and drowsiness [within the first 7 days of switching]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Disciplina de Oncologia, Faculdade de Medicina do ABC	Santo André	São Paulo	Brazil	09060-650

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Newsletter, March 2004

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00525967

Other Study ID Numbers:

217/2005

First Posted:

Sep 6, 2007

Last Update Posted:

Sep 6, 2007

Last Verified:

Sep 1, 2007

Keywords provided by , ,

Additional relevant MeSH terms:

Cancer Pain

Acetaminophen

Methadone

Study Results

No Results Posted as of Sep 6, 2007