NCT01478997已完成1 期
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Centric Study to Determine Whether Flexsure is Safe, Tolerable and Effective in Relieving Symptoms of Moderate Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Laboratory Adverse Events
研究概览
简要总结
This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving symptoms of Moderate Osteoarthritis of the Knee.
详细描述
Primary efficacy variable:
Number of patients showing 20% reduction from baseline in the WOMAC - pain subscale
Secondary efficacy variables:
- Number of patients showing a 50% reduction from baseline in the WOMAC - pain subscale
- Number of patients showing a 20% reduction from baseline in VAS-pain
- Number of patients showing a 50% reduction from baseline in VAS- pain
- Mean change (percentage reduction) in WOMAC scores for pain, stiffness and physical function from baseline, as compared to placebo
- Mean change (percentage reduction) in VAS - pain, as assessed at clinic visits and by daily records in patient diary (First two weeks only)
- Consumption of rescue medication
- Investigator's Global assessment of efficacy
- Subject's global assessment of efficacy
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory male or female patients aged 30-65 years, and diagnosed of OA of the knee according to the ACR clinical and radiographic criteria
- •ARA functional class II or III
- •Kellgren Lawrence radiological severity of Grade II, Grade III OA knee
- •Maximal OA pain on movement, as measured on a 0-100 Visual analog scale (VAS) should be more than 40 and less than 80 in the previous 24 hrs at screening and baseline visits
排除标准
- •Conditions that can mimic OA knee pain, E.g. rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease
- •BMI >35 kg/m2
- •Indication of surgery for OA knee
- •Arthroscopy of either knee in the past year
- •Use of analgesics or any other symptom-relieving medication within 7 days of screening
- •Use of systemic steroids or herbal medication for OA within 4 weeks of screening
- •Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months
- •Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months
- •History of osteoporotic/ osteoarthritic fractures within the past 6 months
- •Pregnant or lactating women or women with inadequate contraceptive measures
- •Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction)
- •Presence of any clinically significant laboratory anomaly
- •Known cases of AIDS (HIV positive)
- •History of Coronary Angioplasty/CABG within the past 2 years
- •Moderate to severe peripheral neuropathy or other neurological disorders
- •Alcohol abuse, medication or drug dependence
- •Concurrent or previous participation in a clinical study within previous 6 weeks
结局指标
主要结局
Laboratory Adverse Events
时间窗: 56 Days
Assessment of Tolerability by the Subject
时间窗: 56 Days
WOMAC - pain subscale
时间窗: 56 Days
Clinical Adverse Events
时间窗: 56 Days
次要结局
- Visual Analog Scale - Pain(56 Days)
- Consumption of Rescue Medication(56 Days)
- Investigator's and Subject's Global Assessment(56 Days)
研究者
研究点 (4)
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