NL-OMON49183已完成2 期
A multi-country, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of STA363 at two concentrations (60 mg/mL and 120 mg/mL) compared to placebo in patients with chronic discogenic low back pain - STA-02
Stayble Therapeutics0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent prior to any study related procedures.
- •2. Male and female patients >=18 and <=70 years.
- •3. Chronic discogenic low back pain present for more than 6 months prior to the
- •screening visit.
- •4. Insufficient response or lack of response to at least 6 months of
- •non-operative treatment (analgesics and/or anti-inflammatory medications
- •[paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), opioids],,
- •physiotherapy, rehabilitation therapy etc.).
- •5. Patients who meet all the following NRS selection criteria:
- •a. Presence of >=5 pain NRS assessments (entries) for 7 consecutive days.
- •b. NRS daily pain scores between 3-9.
- •c. Not more than two ratings «3».
- •Note! Patients must be blinded to the above described NRS selection criteria.
- •6. One or two treatable IVDs of Pfirrmann grade 2 to 3 on MRI at L2/3 to L5/S1
- •as confirmed by a central reader, AND the following criteria are met:
- •a. Treatable IVD(s) must be IVD(s) with the highest Pfirrmann grade observed in
- •the patient (e.g. a patient with one IVD of grade 3 and four IVDs of grade 2 is
- •considered eligible only if IVD of grade 3 will be injected).
- •b. Patients with treatable IVD(s) of grade 2 must have all other lumbar discs
- •rated as grade 1.
- •c. Not more than two IVDs of grade 3 at any lumbar level.
- •d. No IVDs of grade 4 or 5 at any lumbar level.
- •7. Ability to understand the written and verbal information about the study.
排除标准
- •1. Treatment with any investigational product within 3 months prior to the
- •screening visit.
- •2. Patients with more than two painful IVDs.
- •3. A painful IVD above L2/3 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. Evidence of prior lumbar vertebral body fracture or trauma.
- •8. Need for spinal decompression assessed by the Investigator.
- •9. Presence of IVD extrusion or sequestration, or other radiologic findings
- •that in the opinion of the investigator disqualify the patient from being
- •10. Spondylolisthesis or retrolisthesis Grade 2 and above or spondylolysis at
- •the index or adjacent level(s).
- •11. Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting
- •the index IVD.
- •12. Patients previously included in the study.
- •13. Patients suffering from psychosomatic pain in the opinion of the
- •Investigator.
- •14. Leg pain of compressive origin.
- •15. Patients requiring continuous treatment with warfarin or other
- •anticoagulant therapy.
- •16. History of significant neurologic or psychiatric disorders including
- •dementia or seizures.
- •17. Known alcohol and/or drug abuse.
- •18. 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.
- •19. Pregnant or lactating females, or intention to become pregnant within the
- •study period.
- •20. Known allergy to any of the components of the drug product or placebo.
- •21. Known allergy or intolerance to the contrast agent Omnipaque®.
- •22. Known opioid allergy or intolerance.
- •23. Any other condition that, in the opinion of the Investigator, precludes the
- •patient from taking part in
- •this study.
- •24. Any specific contraindication for MRI such as claustrophobia, intracranial
- •clips or pacemakers.
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