Painful Diabetic Neuropathy Clinical Trial
Official title:
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
Verified date | March 2013 |
Source | Bial - Portela C S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.
Status | Completed |
Enrollment | 557 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 NRPS in the last 4 diary entries before randomisation. 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bial - Portela C S.A. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ?Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period. | 17 weeks | No |
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