NCT01293955已完成4 期
A Randomized, Double Blinded, Parallel Group, Placebo-controlled Clinical Trial to Assess the Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Knee MRI
研究概览
简要总结
- A Pilot study
- Randomized and Double-blinded
- Placebo controlled
- In 2 parallel group (JOINS 200mg:Placebo = 1:1)
- Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months)
- Provide rescue medicine throughout whole clinical trial period.
详细描述
-
Assessment of Efficacy
-
Knee MRI(Magnetic resonance imaging):
- Assessment of cartilage volume, thickness in target knee
- GAG(glycosaminoglycan) concentration of target knee
- Assessment of Whole-Organ Magnetic Resonance Imaging Score (WORMS) of target knee
- Knee radiography:
- Assessment of changes in minimal medial JSW(Joint Space Width) of target knee.
- Knee pain(VAS)
- Assessment changes of pain in target knee.
- K-WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index for Korean)
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
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A female is eligible if she is of:
- •Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
- •Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
- •Pregnancy test result of negative at screening
- •Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria.
- •ACR Criteria : With Knee pain and satisfied at least 1 of 3 (① age > 50 years, morning stiffness < 30 minute, ③ Presence of Crepitus and Osteophytes on motion)
- •Appropriately signed and dated informed consent has been obtained
排除标准
- •Rheumatoid arthritis or inflammatory arthritis.
- •Bilateral total knee replacement already treated, or planning for the procedure.
- •Knee prosthesis already implanted, or foreseen within the next year.
- •Clinically significant hip osteoarthritis.
- •Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula).
- •Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.).
- •MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,.
- •Allergic reaction to Clinical trial medication.
- •Other clinical trial drugs during the 1 month prior to the screening visit.
研究组 & 干预措施
JOINS 200mg
Experimental
One tablet of JOINS 200mg is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with JOINS 200mg for another 1 year.
干预措施: JOINS 200mg (Drug)
Placebo
Placebo Comparator
One tablet of Placebo is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with Placebo for another 1 year.
干预措施: Placebo (Drug)
结局指标
主要结局
Knee MRI
时间窗: up to 4 times
次要结局
- Knee radiography(up to 4 times)
- K-WOMAC(up to 6 times)
- Knee pain(VAS)(up to 6 times)
- Consumption of rescue medication(up to 6 times)
- Biomarker(up to 6 times)
研究者
研究点 (1)
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