ACTRN12615000885594已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Analgesic Efficacy and Safety of Oral CMX-020 in Subjects with Symptoms of Sciatica Resulting from Lumbosacral Radiculopathy.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •adult male or female between the ages of 18-75 years,
- •- The subject has a current diagnosis of lumbar radiculopathy with a duration of greater than 6 weeks, defined by all of the following:
- •i. Pain radiating into one leg in a distribution consistent with lumbar radiculopathy.
- •ii. Positive straight leg raise (L5, S1) or positive femoral stretch test (L3, L4).
- •iii. Confirmation of diagnosis by CT or MRI performed no more than 6 months before Screening Visit 1. The exam should demonstrate pathology at a location consistent with the clinical symptoms of radicular pain and nerve root irritation.
- •iv. Mean pain score of >4 on the 11 point NRS scale for average leg pain over the last 24 hours” for at least 5 of 7 days prior to randomization. This score must be greater than mean average back pain over the last 24 hours” score for the same period.
- •- subject must be on a stable analgesic regimen for the treatment of sciatic pain and must be willing to continue that regimen for the duration of the study.
- •- if female of child bearing potential; must be surgically sterile, or practicing a medically acceptable form of contraception. Must have a negative urine pregnancy test at screening and check-in and be non-lactating.
- •- if male; must agree to use a condom if engaging in sexual intercourse at any time during the study.
- •- good health as determined by a physician.
- •- negative urine toxicology screen for drugs of abuse during screening and baseline treatment period 1 visit.
- •- negative for hepatitis B surface antigen, hepatitis C antibody and HIV at screening visit.
排除标准
- •- medical history of hypertension, hypotension or postural hypotension.
- •- history or family history of seizure, including juvenile febrile seizure.
- •- history of head trauma, metabolic disorder, alcohol or drug withdrawal, or CNS infection.
- •- recent history of syncope.
- •- medical condition other than lumbar radiculopathy that is not well controlled with treatment or is deemed CS by the PI.
- •- diagnosis of complex regional pain syndrome, acute spinal cord compression, severe or progressive lower extremity weakness/ numbness, bowel/bladder dysfunction, back pain due to secondary infection or tumour or confirmed/suspected neoplasm.
- •- undergone surgical procedure for back pain will be evaluated for study eligibility on a case by case basis and may be excluded at the discretion of PI.
- •- received a nerve or plexus block, including epidural steroid injections or facet blocks, within 2 weeks prior to screening visit.
- •- radicular pain involving more than one spinal nerve.
- •- clinically significant abnormal ECG at screening.
- •- history of long QT syndrome or a QTcF interval > 450 msec at screening.
- •- participated in an investigational study within past 30 days or 5 half lives of the investigational drug (whichever is longer) prior to study drug administration.
- •- major psychiatric condition (e.g. major depression, schizophrenia) or who has clinically significant anxiety or depression as defined by a HADS score greater than 10.
- •- intolerant to oxycodone.
- •- received MAO inhibitors within 14 days prior to the screening visit.
- •- positive alcohol or drugs of abuse test at any visit (except for opioids if currently on prescribed or OTC opioids used as analgesic regimen).
- •- history or clinical significant disease or abnormal surgical or medical condition which might compromise gastrointestinal, hepatic, or renal function and alter the absorption, distribution, metabolism, or excretion of study drug.
- •- AST or ALT> twice ULN or creatinine > 1.9 mg/dl at screening or any lab abnormality which in opinion of Investigator would contraindicate study participation.
- •- Creatinine clearance of less than 60 mL/min during the Screening visit.
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