Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
Stopped: Low inclusion rate
Belgium33 participantsStarted 2018-12-03
Plain-language summary
Evaluation of topical treatment with lidocaine 5% patch (daily administration) or capsaicin 8% patch (periodic administration - upon reoccurrence of pain symptoms) in adult patients suffering from localized neuropathic pain (LNP) across a wide variety of etiologies, with a duration between 1 and 24 months (subacute to chronic neuropathic pain (NP)).
Who can participate
Age range18 Years
SexALL
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Patients eligible for inclusion in this study must fulfil all of the following criteria:
* Subjects should be capable of giving their informed consent with sufficient knowledge of the Dutch, French or German language;
* Males and females, 18 years and older;
* Be assessed as suffering from moderate to severe neuropathic pain across the screening process with pain intensity (numeric rating scale - NRS) ≥ 4/10,
* At the time of screening pain symptoms have to be present for at least one (1) month, with a maximum of 24 months;
* Sensory disturbances present in the skin area of maximal pain;
* At the time of screening pain is clearly related to the presence of a localized neuropathic pain syndrome.
* Male or female patients of child producing potential\* must agree to use contraception or take measures to avoid pregnancy during the study and until after the final treatment;
* Women can only be included after negative pregnancy test;
Exclusion Criteria:
* Age \< 18;
* Pregnant and breastfeeding women;
* Infection in the painful skin region;
* Poorly healed or non-healed wound or scar in the painful skin region as well as presence of cutaneous abnormalities (non-intact skin barrier) within the painful skin region related to dermatological conditions;
* Known and/or strong suspicion of allergy to the study medication, known skin disorder (resulting in disruption of the normal skin barrier);
* Previous treatment with any of the three medications included in the study protocol for …