We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00525967
Recruitment Status : Unknown
Verified September 2007 by Faculdade de Medicina do ABC.
Recruitment status was:  Recruiting
First Posted : September 6, 2007
Last Update Posted : September 6, 2007
Sponsor:
Information provided by:
Faculdade de Medicina do ABC

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 Type : Interventional  (Clinical Trial)
Estimated 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 : February 2006
Estimated Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00525967     History of Changes
Other Study ID Numbers: 217/2005
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: September 6, 2007
Last Verified: September 2007

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

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Methadone
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Antitussive Agents
Respiratory System Agents