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NCT00525967 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00525967
Other study ID # 217/2005
Secondary ID
Status Unknown status
Phase Phase 2/Phase 3
First received September 5, 2007
Last updated September 5, 2007
Start date February 2006
Est. completion date October 2007

Study information
Verified date September 2007
Source Faculdade de Medicina do ABC
Contact Daniel IG Cubero, MD
Phone 55-11-81799103
Email danielcubero@uol.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 50
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil Disciplina de Oncologia, Faculdade de Medicina do ABC Santo André São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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 J — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 A — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain intensity and time to equianalgesic effect within the first 7 days after switching
Secondary Degree of nausea, vomiting, obstipation, xerostomia and drowsiness within the first 7 days of switching
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