Efficacy and Safety of Eslicarbazepine Acetate (BIA 2 093) as Therapy for Patients With Painful Diabetic Neuropathy: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

Bial - Portela C S.A.0 个研究点目标入组 557 人开始时间: 2007年11月最近更新: 2016年6月22日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 557
主要终点: Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Written informed consent to participate in the study
•Men and women aged 18 years or older
•Diagnosis of diabetes mellitus Type 1 or 2
•Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
•Stable glycemic control: (total glycated haemoglobin [HbA1c] level ≤ 11% at screening)
•Cooperation and willingness to complete all aspects of the study
•Completion of at least 4 daily diaries during the week preceding randomisation
•A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

排除标准

•Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
•Significant or unstable medical or psychiatric disorders
•Drug or alcohol abuse in the preceding 2 years
•Peripheral vascular disease with a history of amputation, except amputation of toes
•Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
•Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)
•Previous participation in any study with eslicarbazepine acetate
•Pregnancy or breast feeding
•History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
•History of non-compliance
•Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
•Participation in a clinical study within 3 months prior to screening
•Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial