Status:
TERMINATED
Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 loc...
Detailed Description
A multicentre, randomized, open-label comparative trial evaluating topical treatment options versus oral systemic treatment in adult patients suffering from localized neuropathic pain (LNP) syndromes....
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03348735
Start Date
December 3 2018
End Date
April 19 2021
Last Update
April 28 2021
Active Locations (13)
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1
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650
2
AZ Monica (campus Antwerpen)
Antwerp, Belgium, 2018
3
AZ Klina
Brasschaat, Belgium, 2930
4
AZ Sint Jan Brugge
Bruges, Belgium, 8000