E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuropathic pain due to Peripheral nerve damage |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10011302 |
E.1.2 | Term | Peripheral nerve injuries |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034586 |
E.1.2 | Term | Peripheral nerve injury |
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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 |
The primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch (Versatis 5% medicated plaster). The primary outcome measure is the predictive role for these measures for obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point reduction in median pain intensity (measured from a baseline week to the last week of treatment).
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E.2.2 | Secondary objectives of the trial |
Pain assesments reported by the patients with the use of questionnaires. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with focal neuropathic pain for at least 3 months following a peripheral nerve injury due to trauma or surgery are eligible. The neuropathic pain should be within a skin area with positive or negative sensory signs corresponding to the territory of the injured peripheral nerve/nerves 2. Patients aged 18 years or above with a pain intensity of at least 4 on a 0-10 point NRS scale at the first visit (screening) 3. Intact skin i the area where the plaster is to be applied. 4. Written informed consent has been obtained. |
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E.4 | Principal exclusion criteria |
1. Other diseases: Diabetes, symptomatic cardiovascular, liver or kidney diseases, neurological diseases other than peripheral nerve injury. 2. Other pains that may make it difficult to discriminate these pains from the pain originating from the nerve injury. 3. Allergy to lidocaine or some of the substances in the medicine. 4. Skin diseases in the area where the patches are to be applied. 5. Pregnant or lactating women. Fertile women must be in sufficient contraception and have a negative pregnancy test. 6. Persons who cannot cope with the study or are unable to conduct the study because of lack of understanding of danish, mental illness, abuse of alcohol or drugs. 7. Patients who are in treatment with class I antiarrhythmic agents. 8. Patients who were in treatment with Na2+ -channel blockers in the recent month or in treatment with capsaicin in the recent 3 months. 9. Patients in treatment with TENS or acupuncture.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the predictive role for these measures in obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point reduction in median pain intensity (measured from the baseline week to the last week of treatment, measured on the NRS scale 0-10).
AMENDMENT: Because of technical difficulties and the inappropriateness of using SEP in our patient population, we are not performing somatosenory evoked potential examinination (SEPs). The study objective is to evaluate if the degree of preserved nociceptors (Aδ and C fibers), Aβ fibers and and the degree of dynamic mechanical allodyni can be used as a predictor for the effect of Versatis lidocaine patch. We are therefore using vibration thresholds as the only tool to examine the conserved large nerve fibers (Aβ fibers). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 0 |
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
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Estimated LPLV: April 31st 2011
AMENDMENT: ESTIMATED LPLV: JANUARY 1ST 2012 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |