Trial Outcomes & Findings for Study of D-Methadone in Patients With Chronic Pain (NCT NCT00588640)

Last Updated: 2016-08-10

Results Overview

The number of patients who reached a safe and well tolerated dose of d-methadone

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

2 years

Results posted on

2016-08-10

Participant milestones
Measure	Patients Receiving D-methadone 40 mg Patient Receiving D-methadone 40 mg
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Patients Receiving D-methadone 40 mg Patient Receiving D-methadone 40 mg
Overall Study Physician Decision	1
Overall Study Ineligible Patient	1

Study of D-Methadone in Patients With Chronic Pain

Baseline characteristics by cohort
Measure	Patients Receiving D-methadone 40 mg n=10 Participants Patient Receiving D-methadone 40 mg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

Timeframe: 2 years

The number of patients who reached a safe and well tolerated dose of d-methadone

Outcome measures
Measure	Phase I, Cohort l n=8 Participants oral d-methadone 40 mg d-Methadone: 8 subjects to receive 40 mg d-Methadone twice a day
Number Who Reached a Safe Dose	8 participants

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	Patients Receiving D-methadone 40 mg n=9 participants at risk Patient Receiving D-methadone 40 mg
General disorders Pain - Neck	11.1% 1/9 • Number of events 1
General disorders Pain - Back	11.1% 1/9 • Number of events 1

Other adverse events
Measure	Patients Receiving D-methadone 40 mg n=9 participants at risk Patient Receiving D-methadone 40 mg
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1
General disorders Fatigue (asthenia, lethargy, malaise)	22.2% 2/9 • Number of events 2
Blood and lymphatic system disorders Glucose, high (hyperglycemia)	11.1% 1/9 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	11.1% 1/9 • Number of events 1
Psychiatric disorders Mood alteration - Anxiety	11.1% 1/9 • Number of events 1
General disorders Nausea	11.1% 1/9 • Number of events 1
General disorders Pain - Joint	11.1% 1/9 • Number of events 1
General disorders Pain - Pain NOS	11.1% 1/9 • Number of events 1
Cardiac disorders Prolonged QTc interval	33.3% 3/9 • Number of events 3
Skin and subcutaneous tissue disorders Pruritus/itching	11.1% 1/9 • Number of events 1
General disorders Sweating (diaphoresis)	11.1% 1/9 • Number of events 1
Renal and urinary disorders Urinary frequency/urgency	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Vomiting	22.2% 2/9 • Number of events 2

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