EUCTR2013-004876-37-BG进行中（未招募）1 期
A 4 week phase 2a, multicentre, randomised, double-blind, placebo-controlled add-on study into safety, tolerability and efficacy of 200 mg t.i.d. of PL37 in patients with peripheral neuropathic pain of diabetic origin treated with pregabalin or gabapentin.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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:
- •1. Willing and able to provide written informed consent prior to any study related procedures
- •2. Male or female, aged =18 years and =75 years
- •3. Willing to comply with all study procedures and be available for the duration of the study
- •4. Diagnosed (confirmed by pain specialist or endocrinologist) with peripheral neuropathic pain of diabetic origin
- •5. Neuropathic pain lasting for at least 3 months
- •6. Mean 24-hour average pain intensity score of 4 or higher, as calculated from a minimum of 5 NRS ratings recorded by the patient over the 7 days period after the screening and prior to the randomisation visit and also between the randomisation and the dispensing visit (this eligibility criterion will be provided by IVR system/ePRO diary)
- •7. Stable treatment with pregabalin or gabapentin for at least one month prior to screening visit
- •8. Adequately controlled diabetes (HbA1c =10% or 86 mmol/mol)
- •9. Women of reproductive potential must use highly effective contraception from screening to 1 week after end of study treatment. (A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly, such as implants, injectable, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomised partner)
- •10. Men of reproductive potential must use condoms from screening to 1 week after end of study treatment
- •11. HADS-Depression score = 11
- •12. Stable dose of any allowed central nervous system (CNS) - acting medications for at least one month prior to screening visit
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Unstable angina, heart failure and significant pulmonary disease requiring home oxygen
- •2. Severe renal disease defined as eGFR < 30 mL/min/1,73m2 calculated by using either the CKD-EPI or MDRD equation
- •3. Liver disease or any liver function test > 2.5 x ULN
- •4. Other painful medical conditions that could interfere with assessment of study outcomes (rheumatoid arthritis, inflammatory bowel disease, mechanical lower back disorders)
- •5. Use of disallowed concomitant medications (systemic analgesic, opioids or anti-inflammatory medications [other than paracetamol] or capsaicin cream during two weeks prior to screening visit)
- •6. Recent (last 2 weeks) febrile illness that precludes or delays participation
- •7. Inability to swallow study medication
- •8. Pregnant females as determined by positive urine pregnancy at randomisation visit
- •9. Breastfeeding females
- •10. Known hypersensitivity or intolerance to components of the study product(s)
- •11. Treatment with another investigational drug or other intervention during the last 4 weeks prior to screening visit
- •12. History of drug/alcohol abuse
- •13. History of severe psychiatric disorder
- •14. Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject’s full compliance with or completion of the study
研究者
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