CompletedPhase 1/2

Tariquidar-ondansetron Combination in Neuropathic Pain

United States24 participantsStarted 2021-01-31

Plain-language summary

Prospective, randomized, double-blind, placebo controlled, cross-over proof of concept study. To determine the pharmacokinetics and tolerability of co-administration of 5-HT3R antagonist ondansetron with a P-glycoprotein inhibitor tariquidar, in patients with neuropathic pain.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Age 18-65;
✓. Documented diagnosis of neuropathic pain due to damage or disease affecting the peripheral nervous system;
✓. At least Probable neuropathic pain grading1;
✓. Pain duration \>3 months;
✓. Average pain intensity ≥4 on 0-10 numerical rating scale (NRS).

Exclusion criteria

✕. Current pregnancy or lactation;
✕. Moderate-severe kidney or liver dysfunction;
✕. Active cardiac arrhythmias (non-sinus rhythm), Long QT syndrome, or QTc interval \>450msec;
✕. Congestive heart failure
✕. Abnormal troponin values at screening visit;
✕. Current treatment with MAO inhibitors, mirtazapine, SSRI antidepressants, or SNRI medications duloxetine or venlafaxine;
✕. Current treatment with tapentadol, tramadol, or fentanyl;
✕. Current treatment with P-glycoprotein substrate drugs with narrow therapeutic window, e.g. digoxin;

What they're measuring

Concertation-time Profile of Ondansetron in Plasma, Measured by the Area Under the Concentration-time Curve (AUC)

Timeframe: Measurements over 240 minutes, extrapolated to infinity

Cerebrospinal Fluid to Plasma Concentration Ratio of Ondansetron

Timeframe: anytime between 0-240 minutes

Trial details

NCT IDNCT04603066

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-21

Results submitted2024-11-11

View on ClinicalTrials.gov More Neuropathic Pain trials