EUCTR2010-019100-23-DE进行中（未招募）不适用
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 468
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
- •1. Male and female outpatients aged 18 years or older. Female subjects are not breastfeeding and are of nonchildbearing potential, defined as surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or at least 2 years postmenopausal (spontaneous amenorrhea for at least 24 months before Visit 1), or if of childbearing potential, subjects agree to use a medically acceptable nonhormonal method of contraception
- •2. Diagnosis of Type 1 or Type 2 diabetes mellitus.
- •3. Pain due to bilateral peripheral polyneuropathy caused by Type 1 or Type 2 diabetes mellitus. Daily pain should be present for at least 6 months and should have begun in the feet with relatively symmetrical onset. The diagnosis of DNP must be confirmed by a score of at least 3 on the investigator rated Part B of the Michigan Neuropathy Screening Instrument at Visit 1 (Screening).
- •4. Have stable glycemic control, as assessed by the investigator, and have glycosylated hemoglobin proportion of less than or equal to 11% before randomization.
- •5. A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment; the mean is determined by averaging all available daily scores from the 24 hour average pain assessment in the subject eDiary from the last 7 days before Visit 3. The period between Visit 2 and Visit 3 can vary between 7 to 10 days. To be randomly assigned, a subject must have at least 5 assessments of 24 hour average pain from the last 7 days prior to randomization.
- •6. A subject rated score at Visit 3 of 40 mm or more on a 100 mm VAS for DNP during the previous 24 hours.
- •7. Daily eDiaries must be completed for at least 70% of the 7 to 10 days between Visit 2 and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days).
- •8. If not used to treat DNP, subjects are permitted to take nonsteroidal anti inflammatory drugs and selective serotonin reuptake inhibitors if they were kept on a stable dose for 1 month prior to Screening and are foreseen to remain stable throughout the study.
- •9. Competent and able to freely give own informed consent.
- •10. A degree of education and understanding sufficient to communicate intelligibly with the investigator and other study center staff.
- •11. Considered reliable and agree to keep all appointments for protocol required study visits, tests, and procedures.
- •12. Female subjects of childbearing potential must have a negative serum pregnancy test at Visit 1.
- •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
- •1. Historical exposure to drugs known to cause neuropathy, such as vincristine, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have caused neuropathy.
- •2. Other chronic pain conditions not associated with DNP. However, subjects will not be excluded if all the following criteria apply:
- •Pain is located in a different region of the body,
- •Pain intensity is not greater than the pain intensity of DNP, and
- •Subject can assess DNP pain independently of the other pain condition.
- •3. Significant skin lesions (active infection, ulcer, etc) that could interfere with pain assessment.
- •4. Peripheral vascular disease with a history of amputation, except amputation of toes.
- •5. Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications.
- •6. Subjects who previously participated in a clinical study with ESL.
- •7. Current or previous (within the past year) axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol abuse, history of suicide attempt, or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM IV) American Psychiatric Association, 2000 criteria, as determined by the investigator.
- •8. Serious or unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic, gastrointestinal or hematologic illness, symptomatic peripheral vascular disease, or other medical condition that the investigator considers would compromise participation or likely cause hospitalization during the study.
- •9. Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead ECG as determined by the investigator.
- •10. Subjects taking the following drug classes and individual drugs are excluded: benzodiazepines (except short half life sleep agents), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletine, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants, tricyclic antidepressants, and serotonin norepinephrine reuptake inhibitors. These drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide.
- •11. Taking excluded medications that cannot be stopped prior to Visit 2.
- •12. Plasma sodium less than 130 mmol/L, alanine or aspartate aminotransferases greater than 2.0 times above the upper limit of the normal range, white blood cell count less than 3000 cells/mm3, or any other relevant clinical laboratory abnormality that, in the investigator’s opinion, can compromise the subject’s safety.
- •13. Prior renal transplant or current renal dialysis.
- •14. History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine.
- •15. Subjects with a positive Visit 1 drugs of abuse screen test will be excluded from the study, except for medications used to treat a medical condition (including DNP) and reported as such by the subject at Visit 1 (screening visit). These subjects can wash out the medication and be retested at Visit 3. All subjects must have a negative result at Visit 3.
- •16. An estimated creatinine clearance of less than 50 mL/min calculated using the 4 variable Modification of Diet in Renal Dis
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