NCT03383471Unknown3 期
A Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Invossa K Injection in Patients Diagnosed as Knee Osteoarthritis With Kellgren & Lawrence Grade 2
Kolon Life Science17 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2018年2月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 146
- 试验地点
- 17
- 主要终点
- IKDC (International knee documentation committee) Subjective Knee Evaluation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren & Lawrence grade 2 knee osteoarthritis.
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)
盲法说明
Double Blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 19 and older
- •Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee.
- •Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee.
- •Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- •BMI should fall between 18.5 and 30
- •Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology guidelines, and applies to one of the following.
- •Age > 50 years old
- •Morning stiffness < 30 minutes
- •Crepitus and Osteophytes
- •With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
- •Patients with persistent symptoms in spite of conservative therapy for more than 3 months : Improvement of 100 mm VAS are less than 10 mm after 3 months
- •Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
- •Agreed to use an effective contraceptive method during the study period
- •Voluntarily agreed to participate in this study, and signed the informed consent form
排除标准
- •Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- •Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
- •Patients with severe pain in other areas that could effect the diagnosis of the symptoms
- •Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- •History of surgery like arthroendoscopy within the past 6 months on the target knee
- •Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
- •History of injection within the past 3 months on the target knee
- •Pregnant or breastfeeding female
- •With another joint disease apart from degenerative arthritis
- •Patients with hepatitis including carrier
- •Patients with HIV and an infectious disease which is clinically uncontrolled
- •Patients who have any of the following clinically significant diseases or have a medical history within 6 months :
- •Clinically significant heart diseases which are considered by the investigator
- •Uncontrolled hypertension : if the systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg in a sitting position
- •Kidney disease
- •Liver disease
- •Endocrine disease
- •Uncontrolled diabetes mellitus : HbA1c ≥ 9%
- •Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease
- •Genetic diseases (hyperkinesia, collagen gene abnormality)
- •Medical history of past or current malignant tumor
- •Patients with a history of anaphylactic reactions
- •Patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide, mannitol, dextran 40 or bovine proteins
- •Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
- •Patients who administered the INVOSSA K inj.
- •Considered inappropriate by the investigator for participation in this study
研究组 & 干预措施
Invossa K Inj.
Experimental
Invossa K Inj.
干预措施: Invossa K Inj. (Biological)
Placebo
Placebo Comparator
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
IKDC (International knee documentation committee) Subjective Knee Evaluation
时间窗: Week 0 and 52
Changes in IKDC Subjective Knee Evaluation (score)
100 mm VAS (Visual analogue scale)
时间窗: Week 0 and 52
Changes in 100 mm VAS
次要结局
- IKDC Subjective Knee Evaluation(Week 0, 26 and 39)
- Biomarker (CTX-I) in blood(Week 0, 26, and 52)
- Rescue Medication (Frequency)(Week 0, 4, 12, 26, 39, and 52)
- MRI scan(Week 0, and 52)
- Rescue Medication (Dosage)(Week 0, 4, 12, 26, 39, and 52)
- Drop-out rate(Week 0, 4, 12, 26, 39, and 52)
- Reason of drop-out(Week 0, 4, 12, 26, 39, and 52)
- 100 mm VAS(Week 0, 26 and 39)
- Joint Space Width(Week 0, and 52)
- OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate(Week 26, 39 and 52)
- Biomarker (CTX-II) in urine(Week 0, 26, and 52)
- WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score(Week 0, 26, 39 and 52)
研究者
研究点 (17)
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