Trial Outcomes & Findings for Methadone in Pediatric and Adult Sickle Cell Patients (NCT NCT00761085)
NCT ID: NCT00761085
Last Updated: 2020-01-22
Results Overview
R-Methadone AUC
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
96 hr
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
Methadone-Children
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Children
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
Methadone-Adults
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Adults
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
11
|
12
|
|
Overall Study
COMPLETED
|
12
|
6
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Methadone-Children
n=12 Participants
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Children
n=12 Participants
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
Methadone-Adults
n=11 Participants
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Adults
n=12 Participants
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 2 • n=12 Participants
|
14 years
STANDARD_DEVIATION 3 • n=12 Participants
|
25 years
STANDARD_DEVIATION 6 • n=11 Participants
|
25 years
STANDARD_DEVIATION 7 • n=12 Participants
|
22 years
STANDARD_DEVIATION 5 • n=47 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
7 Participants
n=11 Participants
|
7 Participants
n=12 Participants
|
23 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
5 Participants
n=12 Participants
|
24 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
11 participants
n=11 Participants
|
12 participants
n=12 Participants
|
47 participants
n=47 Participants
|
PRIMARY outcome
Timeframe: 96 hrR-Methadone AUC
Outcome measures
| Measure |
Methadone-Children
n=12 Participants
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Children
n=12 Participants
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
Methadone-Adults
n=11 Participants
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Adults
n=12 Participants
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
|---|---|---|---|---|
|
To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
|
523 (hr*ng/ml)
Standard Deviation 248
|
0 (hr*ng/ml)
Standard Deviation 0
|
637 (hr*ng/ml)
Standard Deviation 324
|
0 (hr*ng/ml)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 72 hrPain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced
Outcome measures
| Measure |
Methadone-Children
n=12 Participants
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Children
n=12 Participants
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
Methadone-Adults
n=11 Participants
Methadone comparison to standard of care for pain management
Methadone: Compare to standard of care for pain management of acute episode of pain
|
Morphine-Adults
n=12 Participants
Morphine standard of Care pain management
Morphine: Standard of care for pain management of acute episode of pain
|
|---|---|---|---|---|
|
Pain Relief
|
8 units on a scale
Standard Deviation 2
|
4 units on a scale
Standard Deviation 3
|
5 units on a scale
Standard Deviation 3
|
5 units on a scale
Standard Deviation 2
|
Adverse Events
Methadone-Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Morphine-Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methadone-Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Morphine-Adults
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place