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:

MedlinePlus related topics: Cancer Nausea and Vomiting Palliative Care

Drug Information available for: Morphine sulfate Methadone Acetaminophen Methadone hydrochloride

U.S. FDA Resources

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

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:

Newsletter, March 2004 This link exits the ClinicalTrials.gov site

Publications:

Ripamonti C, Groff L, Brunelli C, Polastri D, Stavrakis A, De Conno F. Switching from morphine to oral methadone in treating cancer pain: what is the equianalgesic dose ratio? J Clin Oncol. 1998 Oct;16(10):3216-21.

Mercadante S, Casuccio A, Fulfaro F, Groff L, Boffi R, Villari P, Gebbia V, Ripamonti C. Switching from morphine to methadone to improve analgesia and tolerability in cancer patients: a prospective study. J Clin Oncol. 2001 Jun 1;19(11):2898-904.

Mercadante S, Casuccio A, Calderone L. Rapid switching from morphine to methadone in cancer patients with poor response to morphine. J Clin Oncol. 1999 Oct;17(10):3307-12.

Mercadante S, Ferrera P, Villari P, Casuccio A. Rapid switching between transdermal fentanyl and methadone in cancer patients. J Clin Oncol. 2005 Aug 1;23(22):5229-34.

Bruera E, Palmer JL, Bosnjak S, Rico MA, Moyano J, Sweeney C, Strasser F, Willey J, Bertolino M, Mathias C, Spruyt O, Fisch MJ. Methadone versus morphine as a first-line strong opioid for cancer pain: a randomized, double-blind study. J Clin Oncol. 2004 Jan 1;22(1):185-92.

Stockler M, Vardy J, Pillai A, Warr D. Acetaminophen (paracetamol) improves pain and well-being in people with advanced cancer already receiving a strong opioid regimen: a randomized, double-blind, placebo-controlled cross-over trial. J Clin Oncol. 2004 Aug 15;22(16):3389-94.

Mercadante S, Casuccio A, Agnello A, Serretta R, Calderone L, Barresi L. Morphine versus methadone in the pain treatment of advanced-cancer patients followed up at home. J Clin Oncol. 1998 Nov;16(11):3656-61.

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
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013

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