Efficacy, patient acceptability and safety of topical treatment versus systemic treatment: a randomized, multicenter, comparative pragmatic trial in adult patients suffering from diverse localized neuropathic pain (LNP) syndromes. - PELICAN (PrEgabalinLIdocaineCApsaicinNeuropathicpain)

Antwerp University Hospital (UZA)0 个研究点目标入组 591 人开始时间: 2018年10月2日最近更新: 2021年4月26日

试验速览

暂无简介。

•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;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 91

•-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, renal failure.

发起方

Antwerp University Hospital (UZA)