Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT03348735
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03348735
Study Brief:
Protocol Section:
NCT03348735