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Brush-evoked allodynia in patients with peripheral neuropathy before and following intravenous infusion of ondansetron. A randomised, double-blind, placebo controlled, cross-over study. - Ondansetron and brush-evoked allodynia

Brush-evoked allodynia in patients with peripheral neuropathy before and following intravenous infusion of ondansetron. A randomised, double-blind, placebo controlled, cross-over study. - Ondansetron and brush-evoked allodynia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000526-31-SE
Enrollment
Unknown
Registered
2006-11-08
Start date
2007-01-03
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral neuropathy MedDRA version: 8.1 Level: LLT Classification code 10029331 Term: Neuropathy peripheral

Interventions

Trade Name: Zofran Product Name: ondansetron Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous

Sponsors

Section of Clinical Pain Research, Department of Molecular Medicine and Surgery Karolinska Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with a clear etiology to the diagnos of peripheral neuropathy with dynamic mechanical allodynia 2. Age > 18 years 3. Spontaneous ongoing pain 4. Female with childbearing potential must have secure contraception 5. Normal ECG with normal QTc interval Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pain problem outside the area of neuropathy 2. Pain medication with opioids, tramadol, tricyklika, SSRI, SNRI and acetaminophen 3. Heart problem. 4. Neurological disease 5. Liver insufficiency 6. Kidney insufficiency 7. Pregnancy or lactation 8. Hypertonia (blood pressure > 140/90) 9. Bradycardia (pulse frequence <55/min) 9. Known hypersensitivity to ondansetron

Design outcomes

Primary

MeasureTime frame
Main Objective: Does intravenous infusion of 5HT3 receptor blocker ondansetron influence the intensity of brush-evoked allodynia in patients with peripheral neuropathy and dynamic mechanical allodynia. The purpose is to evaluate the involvement of serotonergic endogenous pain modulation.;Secondary Objective: Does intravenous infusion of 5HT3 receptor blocker ondansetron influence the intensity of ongoing spontaneous pain in patients with peripheral neuropathy and dynamic mechanical allodynia. ;Primary end point(s): Change of total brush-evoked pain intensity (area under the curve - the intergrated value of continously measured pain intensity over time) during brushing i.e. lightly stroking of the skin 4 times 60 mm using a brush with a width of 8 mm in the area of dynamic mechanical allodynia following infusion of ondansetron compared with infusion of placebo (saline).—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026