EUCTR2012-000347-28-GB进行中（未招募）1 期
Efficacy and safety of lidocaine 5% medicated plaster in localizedchronic post-operative neuropathic pain
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subjects aged >18 years at Visit 1.
- •Subjects having understood the nature of the trial and having given written informed consent.
- •Subjects able to communicate meaningfully with investigational site staff, to comply with investigational site staff instructions, to comply with the planned use of the IMPs, to complete the questionnaires, and to use the e-diaries.
- •For women of childbearing potential, a negative pregnancy test (sample taken at Visit 1).
- •Subjects suffering from moderate to severe localized chronic PoNP following surgery. Localized chronic PoNP is defined as chronic neuropathic pain on the surface of a single cutaneous area neurologically related to the site of surgery and following surgery (e.g., thoracotomy, total knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
- •The surgery leading to PoNP was performed 3 to 36 months prior to Visit 1.
- •Pain intensity at Visit 1 (subject’s average pain during the last 24 hours before the Enrollment Visit) of =4 on the 11 point NRS.
- •Localized PoNP present for =3 months prior to Visit 1.
- •Douleur neuropathique 4 (DN4) questionnaire score =4/10 at Visit 1.
- •Size of the affected painful skin area is not larger than the size of 3 plasters.
- •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 plasters will be applied.
- •Adherence to the restricted use of concomitant treatments.
- •Compliance with the use of e-diaries; at least 75% of all NRS entries must be available since Visit 1 (assessed at Visit 2).
- •Baseline average pain intensity assessed at Visit 2 (mean of subject’s average pain intensities during the last 24 hours, calculated over the last 7 days of the Enrollment Period) of =4 on the 11 point NRS
- •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 310
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Participation in another trial of IMPs or devices parallel to, or <30 days prior to Visit 1, or previous participation in this trial.
- •Any dependency of the subject to the investigator or the trial site, e.g., employees with direct involvement in the proposed trial or in other trials under the direction of this investigator or trial site, as well as family members of the employees or the investigator.
- •History of dependency or active” drug abuse (alcohol, medication) during the 1 year prior to Visit 1.
- •Evidence or history (during the 3 years prior to Visit 1) of neurotic personality or psychiatric illness.
- •Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
- •Any surgery performed in the 3 months prior to Visit 1, which may affect efficacy or safety assessment, or any surgery scheduled or expected during the trial.
- •Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator’s opinion, may preclude the subject’s participation in the trial.
- •Any painful procedure planned during the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments.
- •History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to Visit 1.
- •Pending litigation due to chronic pain or disability.
- •Other painful conditions in the area of PoNP of infectious or non infectious, inflammatory, or neuropathic causes, or conditions representing a complication of the previous surgical procedure which may affect efficacy or safety assessments.
- •For subjects with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases.
- •Presence of total anesthesia in the cutaneous area neurologically related to the site of surgery (test performed at Visit 1).
- •Hypersensitivity to the IMP, its excipients, or anesthetics of the amide type.
- •Severe cardiac impairment, e.g., New York Heart Association Class =III, myocardial infarction in the 6 months prior to Visit 1, and/or unstable angina pectoris.
- •Any former use of topical lidocaine in the area of localized chronic PoNP.
- •Any use of Class I anti arrhythmic medicinal products (e.g., tocainide, mexiletine, flecainide, and intravenous lidocaine), or local anesthetics containing lidocaine or ketamine in the 3 days prior to Visit 1 or planned during the trial.
- •Known severe renal impairment or a glomerular filtration rate/creatinine clearance <30 mL/min. The Cockroft and Gault formula will be used to calculate the creatinine clearance (sample taken at Visit 1).
- •Known severe hepatocellular insufficiency.
研究者
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