E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029331 |
E.1.2 | Term | Neuropathy peripheral |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Does intravenous infusion of 5HT3 receptor blocker ondansetron influence the intensity of ongoing spontaneous pain in patients with peripheral neuropathy and dynamic mechanical allodynia. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |