Trial Outcomes & Findings for Methadone Versus Morphine for Cancer-Related Pain (NCT NCT00573937)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2016-02-19

Participant Flow

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.

One subjects was assigned to standard control treatment. No subjects received the experimental treatment. No subject data were analyzed.

Participant milestones

Participant milestones
Measure	Methadone Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.	Morphine Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Methadone Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.	Morphine Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
Overall Study Study Terminated	0	1

Baseline Characteristics

Methadone Versus Morphine for Cancer-Related Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methadone Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.	Morphine n=1 Participants Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.	Total n=1 Participants Total of all reporting groups
Age, Continuous	—	48 years n=7 Participants	48 years n=5 Participants
Gender Female	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Male	—	0 participants n=7 Participants	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Due to slow accrual, the study was terminated and no data were analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Population: Due to slow accrual, the study was terminated and no data were analyzed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Methadone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Donald Northfelt, MD

Mayo Clinic

Phone: 480-301-8335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place