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CSF Pharmacokinetics of Ondansetron

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ClinicalTrials.gov Identifier: NCT02901054
Recruitment Status : Completed
First Posted : September 15, 2016
Results First Posted : May 16, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
simon.haroutounian, Washington University School of Medicine

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation of Cerebrospinal Fluid (CSF) Pharmacokinetics of Ondansetron
Study Start Date : August 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: open label infusion ondansetron
  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
A single 15-min intravenous infusion of ondansetron
Other Name: Zofran




Primary Outcome Measures :
  1. CSF to Plasma Concentration Ratio [ Time Frame: 0-180 min from the beginning of infusion ]
    CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901054


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Simon Haroutounian, PhD Dept of Anesthesiology, Washington Univ School of Medicine
  Study Documents (Full-Text)

Documents provided by simon.haroutounian, Washington University School of Medicine:
Informed Consent Form  [PDF] October 18, 2016


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Responsible Party: simon.haroutounian, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02901054     History of Changes
Other Study ID Numbers: 201605080
First Posted: September 15, 2016    Key Record Dates
Results First Posted: May 16, 2018
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents