CSF Pharmacokinetics of Ondansetron

NCT02901054 | Completed Results

• 1 other identifier: 201605080
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

open label infusion ondansetron

EXPERIMENTAL

1. A single 4-mL CSF sample per subject. 2. Serial blood sampling at 0 (pre-infusion), 15, 30, 60, 120, and 180 min after ondansetron administration

Drug: Ondansetron

Interventions

Ondansetron DRUG

A single 15-min intravenous infusion of ondansetron

Also known as: Zofran

open label infusion ondansetron

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years old;
• Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
• Ability to provide informed consent

You may not qualify if:

• Not giving consent to participate in the study;
• Patients with history of or current hepatic or renal insufficiency;
• Patients with BMI ≥ 33;
• Patients with heart failure or active arrhythmias;
• Patients with severe systemic disease that is a constant threat to life;
• Contraindication or allergy to ondansetron;
• Pregnancy or lactation.
• Prisoners

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Simon Haroutounian, PhD
• Organization: Washington University School of Medicine

simon.haroutounian@wustl.edu

3142861715

Study Officials

• Simon Haroutounian, PhD

  Dept of Anesthesiology, Washington Univ School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 15, 2016
• Study Start: August 25, 2016
• Primary Completion: November 17, 2016
• Study Completion: November 17, 2016
• Last Updated: December 27, 2019
• Results First Posted: May 16, 2018

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)