Status:
COMPLETED
Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT00980746
Start Date
November 1 2007
End Date
November 1 2008
Last Update
June 22 2016
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