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Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution.
Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label infusion ondansetron | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | A single 15-min intravenous infusion of ondansetron |
|
| Measure | Description | Time Frame |
|---|---|---|
| CSF to Plasma Concentration Ratio | CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample | 0-180 min from the beginning of infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Haroutounian, PhD | Dept of Anesthesiology, Washington Univ School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
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19 consented, 3 participants withdrew prior to any intervention, and 1 participant excluded before outcomes data collection
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Infusion Ondansetron | The full study cohort (open label, no treatment allocation) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Infusion Ondansetron | The entire cohort of subjects in this open-label study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CSF to Plasma Concentration Ratio | CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample | Posted | Mean | Standard Deviation | Ratio | 0-180 min from the beginning of infusion |
|
|
During the infusion of the study drug and up to the surgery start (1 day)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Infusion Ondansetron | The entire cohort of patients in this open-label study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon Haroutounian, PhD | Washington University School of Medicine | 3142861715 | simon.haroutounian@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2016 | Feb 27, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2016 | Feb 27, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| years |
|
| Sex: Female, Male | one subject withdrew due to cancelled surgery. data not analyzed | Count of Participants | Participants |
|
| Race (NIH/OMB) | one subject withdrew due to cancelled surgery. data not analyzed | Count of Participants | Participants |
|
| Region of Enrollment | Washington University | One subject withdrew due to cancelled surgery. Data were not analyzed. | Number | participants |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |