NCT04778592已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular 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
- 149
- 试验地点
- 24
- 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
Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
详细描述
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
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)
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 has pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s)
- •The subject reports at least moderate pain intensity at screening.
- •The subject's onset of leg pain due to LSRP is at least 3 months
- •The subject has a magnetic resonance imaging (MRI) scan that is normal or shows incidental lesions
- •The subject has a calculated creatinine clearance ≥30 mL/min
- •The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant.
- •body mass index (BMI) <40 kg/m2.
排除标准
- •The subject has previously undergone back surgery
- •The subject is unable to reliably delineate or assess pain by anatomical location/distribution on a body map.
- •The subject has a history of peripheral neuropathy, evidence of peripheral neuropathy, or evidence of mononeuropathy in the same limb of LSRP.
- •The subject has pain due to infection/abscess, hematoma, or malignancy or other pain that may interfere with the assessment of LSRP in the legs.
- •The subject has clinically significant and/or unstable renal, hepatic, hematologic, endocrine, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study
- •The subject has any neurological disease that could interfere with participation in the study (e.g., Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke).
- •The subject has a history or current diagnosis of major psychiatric disorder(s)
- •The subject has a has a history of substance abuse or dependence
- •The subject has clinically significant abnormal electrocardiogram (ECG) findings
- •The subject has received nerve blocks and/or steroid injections for LSRP within the 3 months before screening
- •The subject is unwilling or unable to discontinue current medications for LSRP, including topical agents.
- •The subject is unable to refrain from using prohibited meds during the study, including: NSAID, antiepileptic drugs, steroids, cannabinoids, or major opioids, antidepressants, muscle relaxants, tramadol, or tapentadol.
- •The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, within 30 days the study.
- •The subject is currently participating in another or the same clinical study or participated in another clinical study within 3 months before screening
- •The subject is pregnant or lactating or not practicing adequate birth control
研究组 & 干预措施
ETX-018810
Experimental
Drug: ETX-018810 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
- Number of Subjects With ≥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)
- 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)
- Change From Baseline to Week 4 for Worst Pain(Baseline and Week 4)
- Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4(Treatment period: 4 weeks)
- 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 BPI - Interference Scale From Baseline to Week 4(Baseline to Week 4)
- Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4(Week 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 BPI - Pain 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 RMDQ From Baseline to Week 4(Baseline to Week 4)
研究者
研究点 (24)
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