NCT04688671已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects With Diabetic Peripheral Neuropathic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 22
- 主要终点
- Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS)
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.
详细描述
ETX-018810 is a new chemical entity that is under development as a non-opioid treatment for chronic pain syndromes. ETX-018810 is a prodrug of palmitoylethanolamide (PEA), an endogenous bioactive lipid that has shown efficacy in a broad range of nonclinical inflammatory and neuropathic pain models and in clinical trials in chronic pain indications, including diabetic peripheral neuropathic pain (DPNP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is ≥18 and ≤75 years of age at the time of signing ICF.
- •The subject has a diagnosis of type 1 or 2 diabetes mellitus.
- •The subject has diabetic neuropathy of a symmetrical nature in the lower extremities for ≥6 months to ≤10 years
- •The subject reports at least moderate pain intensity
- •The subject's onset of neuropathic pain is at least 3 months before the screening visit.
- •The subject has used a stable regimen of antidiabetic agents for at least 1 month before the baseline visit or has achieved adequate glycemic control through diet and exercise.
- •The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant.
- •Sexually active male subjects with female partners of childbearing potential and sexually active female subjects of childbearing potential must agree to practice effective contraception or to remain abstinent during the study and for 4 weeks after the last dose of investigational product
- •The subject is capable of giving signed informed consent and agrees to provide authorization for use and release of health records.
排除标准
- •The subject has pain that cannot be clearly differentiated from or that could interfere with the assessment of DPNP.
- •The subject has neurologic and/or circulatory disorders that are unrelated to diabetic neuropathy
- •The subject has a history of hypoglycemia that disturbed consciousness or ketoacidosis that required hospitalization within the 3 months before screening.
- •The subject has clinically significant and/or unstable renal, hepatic, hematologic, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study in the judgment of the investigator.
- •The subject has any neurological disease that could interfere with participation in the study (eg, Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke).
- •The subject has an amputation of a lower extremity. Toe amputation is allowed.
- •The subject has clinically significant abnormal electrocardiogram (ECG) findings at screening or baseline.
- •The subject is likely to require major surgery during the study.
- •The subject is pregnant or lactating.
- •The subject is unwilling or unable to discontinue current medications for neuropathic pain, including topical agents.
- •The subject is unable to refrain from using nonsteroidal anti-inflammatory drugs (NSAIDs); antiepileptic drugs, steroids, cannabinoids, or major opioids, muscle relaxants, tramadol, or tapentadol throughout the study.
- •The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, etc, within 30 days before baseline/Day 1 or anticipates use of such therapies during the study.
研究组 & 干预措施
ETX-018810
Experimental
1000 mg BID for 4 weeks
干预措施: ETX-018810 (Drug)
Placebo
Placebo Comparator
matching placebo BID for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS)
时间窗: baseline to Week 4
Change from baseline in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS) a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
次要结局
- Change in the BPI - Interference Scale From Baseline to Week 4(Baseline to Week 4)
- Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4(Week 4)
- Change in the BPI-Pain Scale From Baseline to Week 4(Baseline to Week 4)
- Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score(Baseline to Weeks 1, 2, 3 and 4)
- Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score(Baseline to Weeks 1, 2, 3 and 4)
- Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4(Baseline to Weeks 1, 2, 3 and 4)
- Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3(Baseline to Weeks 1, 2 and 3)
- Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4.(Week 4)
- Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4(Baseline to week 4)
研究者
研究点 (22)
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