NCT03055845已完成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 Therapeutics1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年3月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Local injection site reactions
研究概览
简要总结
A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intradiscal injection of STA363 or placebo in patients with discogenic low back pain.
15 patients will participate in either of 3 dose groups, each comprising 5 patients:
- Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)
- Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)
- Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-related procedures
- •Chronic discogenic low back pain present for more than 6 months prior to the screening visit
- •20 to 60 years of age at the screening visit
- •Insufficient response to at least 6 months of non-operative treatment (analgesics and/or antiinflammatory medication, physiotherapy etc.)
- •A single lumbar disc appropriate for treatment at L3/4 to L5/S1, based on clinical evaluation by the investigator
- •Pfirrmann grade II-III
- •Ability to understand the written and verbal information about the study
排除标准
- •Treatment with any investigational product within 3 months prior to the screening visit
- •More than one painful intervertebral disc
- •A painful intervertebral disc above L3/4 level
- •Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection
- •Previous lumbar spine surgery
- •Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation)
- •Pfirrmann grade I, IV and V
- •Evidence of prior lumbar vertebral body fracture or trauma
- •Need for spinal decompression assessed by the investigator
- •Presence of disc extrusion or sequestration
- •Patients previously included in the study
- •Patients suffering from psychosomatic pain in the opinion of the investigator
- •Referred leg pain of compressive origin
- •Known alcohol and/or drug abuse
- •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
- •Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator
- •Pregnant or lactating females or intention to become pregnant within the study period
- •Known allergy to any of the components of the drug product or placebo
- •Known opioid allergy or intolerance
- •Patients requiring treatment with warfarin or other anticoagulant therapy
- •Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment
- •Body weight less than 50 kg
研究组 & 干预措施
STA363 dose 1
Experimental
干预措施: STA363 (Drug)
STA363 dose 2
Experimental
干预措施: STA363 (Drug)
STA363 dose 3
Experimental
干预措施: STA363 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Local injection site reactions
时间窗: Up to 4 weeks after injection
Changes in routine safety laboratory parameters
时间窗: Up to 12 weeks after injection
Visual analogue scale (VAS) pain (injection site)
时间窗: Up to 15 minutes after injection
Changes in vital signs
时间窗: Up to 12 weeks after injection
Changes in electrocardiogram (ECG)
时间窗: 1 day after injection
Changes in physical examination findings
时间窗: 1 and 12 weeks after injection
Changes in body weight
时间窗: 12 weeks after injection
Frequency and severity of adverse events
时间窗: Up to 12 weeks after injection
次要结局
- Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)(12 weeks after injection)
- Disc height by MRI(12 weeks after injection)
研究者
研究点 (1)
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