CSF Pharmacokinetics of Ondansetron

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02901054
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Ondansetron	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron
• Actual Study Start Date: Aug 25, 2016
• Actual Primary Completion Date: Nov 17, 2016
• Actual Study Completion Date: Nov 17, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: open label infusion ondansetron A single 4-mL CSF sample per subject. Serial blood sampling at 0 (pre-infusion), 15, 30, 60, 120, and 180 min after ondansetron administration	Drug: Ondansetron; A single 15-min intravenous infusion of ondansetron; Other Names: Zofran

Outcome Measures

Primary Outcome Measures

1. CSF to Plasma Concentration Ratio [0-180 min from the beginning of infusion]

   CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age between 18 and 70 years old;

2. Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;

3. Ability to provide informed consent

Exclusion Criteria:

1. Not giving consent to participate in the study;

2. Patients with history of or current hepatic or renal insufficiency;

3. Patients with BMI ≥ 33;

4. Patients with heart failure or active arrhythmias;

5. Patients with severe systemic disease that is a constant threat to life;

6. Contraindication or allergy to ondansetron;

7. Pregnancy or lactation.

8. Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Simon Haroutounian, PhD, Dept of Anesthesiology, Washington Univ School of Medicine

Study Documents (Full-Text)

• Informed Consent Form - Oct 18, 2016
• Study Protocol and Statistical Analysis Plan - Oct 18, 2016

More Information

Publications

None provided.

• Responsible Party: simon.haroutounian, Assistant Professor, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02901054
• Other Study ID Numbers: 201605080
• First Posted: Sep 15, 2016
• Last Update Posted: Dec 27, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Ondansetron

Study Results

Participant Flow

Recruitment Details	19 consented, 3 participants withdrew prior to any intervention, and 1 participant excluded before outcomes data collection

Arm/Group Title	Open Label Infusion Ondansetron
Arm/Group Description	The full study cohort (open label, no treatment allocation)
Period Title: Overall Study
STARTED	19
COMPLETED	15
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Open Label Infusion Ondansetron
Arm/Group Description	The entire cohort of subjects in this open-label study
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.0 (6.9)
Sex: Female, Male (Count of Participants)
Female	8 50%
Male	7 43.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 6.3%
White	14 87.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	15 93.8%

Outcome Measures

1. Primary Outcome

Title	CSF to Plasma Concentration Ratio
Description	CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample
Time Frame	0-180 min from the beginning of infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label Infusion Ondansetron
Arm/Group Description	The full study cohort (open label, no treatment allocation)
Measure Participants	15
Mean (Standard Deviation) [Ratio]	0.15 (0.05)

Adverse Events

Time Frame	During the infusion of the study drug and up to the surgery start (1 day)
Arm/Group Title	Open Label Infusion Ondansetron
Arm/Group Description	The entire cohort of patients in this open-label study
All Cause Mortality
	Open Label Infusion Ondansetron
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Serious Adverse Events
	Open Label Infusion Ondansetron
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Open Label Infusion Ondansetron
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.