EUCTR2007-002461-12-CZ进行中（未招募）不适用
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 TRIA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 540
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
- •Inclusion criteria at screening
- •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
- •Inclusion criteria at randomisation
- •Completion of at least 4 daily diaries during the week preceding randomisation
- •A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •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
研究者
相似试验
进行中（未招募）
不适用
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 TRIAadult patients with painful diabetic neuropathyMedDRA version: 9.1Level: PTClassification code 10012680Term: Diabetic neuropathyEUCTR2007-002461-12-PTBIAL - Portela & Ca, S.A.540
已完成
不适用
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES:A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY-G40G40PER-108-10BIAL - Portela & Cª, S.A.,13
进行中（未招募）
1 期
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURESAdult patients with newly diagnosed partial-onset seizuresMedDRA version: 18.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852EUCTR2009-011135-13-CZBIAL - Portela & Ca, S.A.900
进行中（未招募）
1 期
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS ADJUNCTIVE THERAPY FOR REFRACTORY PARTIAL SEIZURES IN A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIAL.EUCTR2008-002455-25-CYBIAL - Portela & Cª, SA360
已完成
3 期
A Phase III clinical trial to evaluate the Efficacy and Safety profile of Eslicarbezepine acetate as monotherapy in patients with partial onset SeizuresCTRI/2011/08/001959BIAL Portela Ca SA900