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

Conditions: Peripheral neuropathy
MedDRA version: 8.1Level: LLTClassification code 10029331Term: Neuropathy peripheral

Registration Number: EUCTR2006-000526-31-SE

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures