Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

• Status: Terminated
• Trial end date: 2021-04-19
• Target enrollment: 0
• Participant gender: All

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)).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Antwerp
• Treatments: Capsaicin; Lidocaine; Pregabalin

Criteria

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 the same painful area within the last 12 months at the time of screening;

• Risk of heart failure and/or renal failure.