EUCTR2015-004812-39-SE进行中（未招募）1 期
A prospective, randomised, double-blinded, placebo-controlled, single ascending dose study investigating the safety and local tolerability of STA363 compared to placebo in 15 patients with chronic discogenic low back pain
Stayble Therapeutics0 个研究点开始时间: 2016年11月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Signed informed consent prior to any study-related procedures
- •2. Chronic discogenic low back pain present for more than 6 months prior to the screening visit
- •3. 20 to 60 years of age at the screening visit
- •4. Insufficient response to at least 6 months of non-operative treatment (analgesics and/or anti-inflammatory medication, physiotherapy etc.)
- •5. A single lumbar disc appropriate for treatment at L3/4 to L5/S1, based on clinical evaluation by the investigator
- •6. Pfirrmann grade II-III
- •7. Ability to understand the written and verbal information about the study
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Treatment with any investigational product within 3 months prior to the screening visit
- •2. More than one painful intervertebral disc
- •3. A painful intervertebral disc above L3/4 level
- •4. Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection
- •5. Previous lumbar spine surgery
- •6. Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation)
- •7. Pfirrmann grade I, IV and V
- •8. Evidence of prior lumbar vertebral body fracture or trauma
- •9. Need for spinal decompression assessed by the investigator
- •10. Presence of disc extrusion or sequestration
- •11. Patients previously included in the study
- •12. Patients suffering from psychosomatic pain in the opinion of the investigator
- •13. Referred leg pain of compressive origin
- •14. Known alcohol and/or drug abuse
- •15. Severe intercurrent illness (e.g. rheumatic disease or chronic pain syndrome) or concomitant treatment (e.g. immunosuppressive drugs), which, in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study
- •16. Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator
- •17. Pregnant or lactating females, or intention to become pregnant within the study period
- •18. Known allergy to any of the components of the drug product or placebo
- •19. Known opioid allergy or intolerance
- •20. Patients requiring treatment with warfarin or other anticoagulant therapy
- •21. Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment
- •22. Body weight less than 50 kg
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