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
- Conditions
- adult patients with painful diabetic neuropathyMedDRA version: 9.1Level: PTClassification code 10012680Term: Diabetic neuropathy
- Registration Number
- EUCTR2007-002461-12-CZ
- Lead Sponsor
- BIAL - Portela & Ca, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method