ocalized Neuropathic pain and 5% lidocaine medicated plaster : LiNe

Phase 1

• Conditions: Post operative neuropathic pain (PONP); MedDRA version: 18.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005601-37-FR
• Lead Sponsor: CHU Clermont-Ferrand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-02
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Aged from 18 to 80 years
-Male or female, for women of childbearing potential, a negative pregnancy test
-Patients with PONP following knee surgery
-Patients with neuropathic pain DN4 = 4
-Patients at least 3 months post-surgery
-Patients suffering from at least the allodynic brush-induced mechanical allodynia symptom (DMA) rated as = 5/10 on the numerical scale
-Patient with no localized neuropathic pain symptoms (DN4<4) on the contralateral knee
-Intact skin besides the scar of surgery (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds) in the area where the medicated plasters will be applied
-Naive from Versatis® treatment
-Treated with stable systemic analgesic and planned to remain stable all over the duration of the study
-Cooperation and understanding sufficient to meet study requirements
-Agreement to give written consent
-Insured by French social security
-Included or agreement to be included in the national register of participants in biomedical research
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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

-Pregnant or breastfeeding women of childbearing potential who are sexually active without satisfactory contraception
-Hypersensitivity to the Investigational Medicinal Product (IMP), its excipients, or anesthetics of the amide type
-Patient treated by anti-arythmics (Class I) such as tocainide, méxilétine or other local anesthesic
-Medical and/or surgical history that the investigator or his/her representative considers to be incompatible with the trial.
-Ongoing pathology on the day of the inclusion (open wound, infection, …)
-Patient currently enrolled in another clinical trial involving the use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or being in an exclusion period according to the French law, or having received a total amount of compensation higher than 4500 euros over the 12 months preceding the beginning of the trial
-Patient benefiting from a legal protective measure (guardianship, curatorship).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified