Trial Outcomes & Findings for CSF Pharmacokinetics of Ondansetron (NCT NCT02901054)
NCT ID: NCT02901054
Last Updated: 2019-12-27
Results Overview
CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
0-180 min from the beginning of infusion
Results posted on
2019-12-27
Participant Flow
19 consented, 3 participants withdrew prior to any intervention, and 1 participant excluded before outcomes data collection
Participant milestones
| Measure |
Open Label Infusion Ondansetron
The full study cohort (open label, no treatment allocation)
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Open Label Infusion Ondansetron
The full study cohort (open label, no treatment allocation)
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
one subject withdrew due to cancelled surgery. data not analyzed
Baseline characteristics by cohort
| Measure |
Open Label Infusion Ondansetron
n=16 Participants
The entire cohort of subjects in this open-label study
|
|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 6.9 • n=16 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Race (NIH/OMB)
White
|
14 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants • one subject withdrew due to cancelled surgery. data not analyzed
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants • One subject withdrew due to cancelled surgery. Data were not analyzed.
|
PRIMARY outcome
Timeframe: 0-180 min from the beginning of infusionCSF: plasma ratio of ondansetron at the time of obtaining the CSF sample
Outcome measures
| Measure |
Open Label Infusion Ondansetron
n=15 Participants
The full study cohort (open label, no treatment allocation)
|
|---|---|
|
CSF to Plasma Concentration Ratio
|
0.15 Ratio
Standard Deviation 0.05
|
Adverse Events
Open Label Infusion Ondansetron
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
Simon Haroutounian, PhD
Washington University School of Medicine
Phone: 3142861715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place