Methadone Versus Morphine for Cancer-Related Pain

This study has been terminated.

(Slow accrual.)

Sponsor:

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00573937

First received: December 12, 2007

Last updated: October 4, 2010

Last verified: October 2010

History of Changes

Results First Received: October 4, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Neoplasms Pain
Interventions:	Drug: Methadone Drug: Morphine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the outpatient hematology/oncology clinic, inpatient cancer service, and palliative care unit, at a tertiary medical center from September 2007 to April 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subjects was assigned to standard control treatment. No subjects received the experimental treatment. No subjects were analyzed.

Reporting Groups

	Description
Methadone	No text entered.
Morphine	Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.

Participant Flow: Overall Study

	Methadone	Morphine
STARTED	0	1
COMPLETED	0	0
NOT COMPLETED	0	1

Baseline Characteristics

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Reporting Groups

	Description
Methadone	No text entered.
Morphine	Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Total	Total of all reporting groups

Baseline Measures

	Methadone	Morphine	Total
Number of Participants [units: participants]	0	1	1
Age [units: years] Mean ± Standard Deviation		48 ± 0	48 ± 0
Gender [units: participants]
Female	0	1	1
Male	0	0	0

Outcome Measures

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1. Primary:

The Primary Outcome Measure is Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [ Time Frame: Week 4 ]

Measure Type	Primary
Measure Title	The Primary Outcome Measure is Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit.
Measure Description	No text entered.
Time Frame	Week 4
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Methadone	No text entered.
Morphine	Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.

Measured Values

	Methadone	Morphine
Number of Participants Analyzed [units: participants]	0	1
The Primary Outcome Measure is Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [units: participants]		0

No statistical analysis provided for The Primary Outcome Measure is Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit.

2. Secondary:

Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [ Time Frame: 48 hours ]

Measure Type	Secondary
Measure Title	Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit.
Measure Description	No text entered.
Time Frame	48 hours
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Methadone	No text entered.
Morphine	Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.

Measured Values

	Methadone	Morphine
Number of Participants Analyzed [units: participants]	0	1
Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit. [units: participants]		0

No statistical analysis provided for Whether the Patient Had at Least 33% Reduction From the Baseline Visual Numeric Scale Score for Pain at the Time of the Visit.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Eric E Prommer MD
Organization: Mayo Clinic
phone: 480-301-8000
e-mail: prommer.eric@mayo.edu

No publications provided

Responsible Party:	Eric E. Prommer, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00573937 History of Changes
Other Study ID Numbers:	07-003051
Study First Received:	December 12, 2007
Results First Received:	October 4, 2010
Last Updated:	October 4, 2010
Health Authority:	United States: Institutional Review Board

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