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NCT02901054

CSF Pharmacokinetics of Ondansetron

Completed NA Results posted Last updated 27 December 2019
What this trial tests

NA trial testing Ondansetron in Pain in 19 participants. Completed in 17 November 2016.

Timeline
25 August 2016
Primary endpoint
17 November 2016
17 November 2016

Quick facts

Lead sponsorWashington University School of Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment19
Start date25 August 2016
Primary completion17 November 2016
Estimated completion17 November 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 70, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CSF to Plasma Concentration Ratio Primary · 0-180 min from the beginning of infusion

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

GroupValue95% CI
Open Label Infusion Ondansetron0.15± 0.05

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Plasma and cerebrospinal fluid pharmacokinetics of ondansetron in humans.
    Chiang MD, Frey K, Lee C, Kharasch ED, et al · · 2021 · cited 7× · PMID 32495990 · DOI 10.1111/bcp.14412

Verify or expand the search:

Other trials of Ondansetron

Trials testing the same drug.

Other recruiting trials for Pain

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02901054.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing