Methadone Versus Morphine for Cancer-Related Pain

NCT00573937 | Terminated Phase 2 Results

• 1 other identifier: 07-003051
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare methadone with morphine in the management of moderate to severe cancer pain.

Conditions

Neoplasms; Pain

Keywords

Neoplasms; Pain; Methadone; Morphine

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Pain Scale Score

  Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain. Response to treatment is defined as a 33% reduction in pain score from the baseline to the Week 4 pain score.

  Baseline, Week 4

Secondary Outcomes (1)

• Change in Numeric Pain Scale Score

  48 hours

Study Arms (2)

Methadone

ACTIVE COMPARATOR

Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.

Drug: Methadone

Morphine

ACTIVE COMPARATOR

Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.

Drug: Morphine

Interventions

Methadone DRUG

Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.

Also known as: Methadone Hydrochloride, Methadose, Dolophine Hydrochloride

Methadone

Morphine DRUG

Oral slow-release morphine 15 mg every 8 hours, and oral immediate-release morphine 10 mg every 4 hours as needed for breakthrough pain.

Also known as: Morphine Sulfate

Morphine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a telephone
• Age: patient must be 18 years or older and less than 70 years of age
• Life expectancy of 3 months or greater
• No prior use of step-3 opioids (step 2 opioids are allowed)
• Provision of informed consent
• Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status)
• Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain
• Moderate to severe cancer related pain that requires the use of step-3 opioids
• Normal renal function
• Must live no more than 1 hour away from clinic
• Patient must have pain severity of 5-7/10 on a 0-10 pain scale

You may not qualify if:

• Nursing home patients
• Obvious cognitive dysfunction
• Intractable nausea or vomiting
• A true allergy or intolerance to opioids
• Unstable renal function
• Undergoing therapeutic procedures likely to influence pain during the study period
• Gastrointestinal pathology or surgery that influences absorption of morphine or methadone
• Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days
• History of drug seeking behavior
• Respiratory compromise
• Treatment with bisphosphonates within the last month
• Use of MAO inhibitors
• Drugs that interfere with CYP34A or CYP2D6
• Drugs that interfere with morphine metabolism
• Retroviral therapies

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Due to slow accrual of subjects, the study was terminated after one subject started in the standard control group (morphine). No subject received investigational study drug (methadone). Therefore no data were analyzed.

Results Point of Contact

• Title: Donald Northfelt, MD
• Organization: Mayo Clinic

northfelt.donald@mayo.edu

480-301-8335

Study Officials

• Donald Northfelt, M.D.

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 19, 2016
• Results First Posted: November 4, 2010

Record last verified: 2016-01

Locations

US (1)