NCT02594176Unknown不适用
A Randomised, Double-blind, Placebo Controlled Study of Topical FLEXISEQ® for the Treatment of Osteoarthritis of the Knee in Patients Contraindicated for or With Clinical Intolerance to NSAIDs
Pro Bono Bio1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- WOMAC pain score
研究概览
简要总结
Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical intolerance to NSAIDs.
Secondary Objectives
- To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and improvement of joint function in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.
- To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.
详细描述
This post marketing clinical follow-up, randomised, double-blind study comparing the efficacy and tolerability of topical FLEXISEQ® with placebo for the treatment of osteoarthritis of the knee in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee will have a total individual treatment period of 12 weeks.
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)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent prior to any study-mandated procedure
- •Willing and able to comply with study requirements
- •Outpatients with an age ≥ 50 (starting from the day after the 50th birthday)
- •Patient for whom their knee pain is the worst pain in the body and is able to identify the predominantly painful (target) knee
- •Patient has a primary diagnosis of Functional Class I-III OA of the target knee and patient meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
- •NSAID contraindicated or clinically intolerant
- •Females able to conceive (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate
- •If female and able to conceive, patient has a negative urine pregnancy test at screening
排除标准
- •General exclusion criteria
- •Planned treatment or treatment with another investigational drug within 30 days prior to randomisation
- •Patients who are inmates of psychiatric wards, prisons, or other state institutions
- •Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- •Pregnancy or lactation
- •Any planned or expected hospitalisation within the study period
- •Patients not able to perform the WOMAC test (physically handicapped or immobile patient, e.g. wheel-chair bound)
- •Any health condition which, in the investigator's opinion means the patient is likely to be unable to complete the 12 week study Medical history related exclusion criteria
- •Skin lesions or dermatological diseases in the treatment area
- •Extreme obesity (BMI > 35)
- •Uncontrolled hypertension
- •Requiring dialysis
- •Hepatocellular insufficiency preventing use of paracetamol
- •Alcohol abuse
- •Intolerance to paracetamol
- •Malignancy within the past 2 years
- •Morbus Meulengracht/Gilbert Syndrome
- •Neurological or psychiatric disorders compromising pain rating by the patient, such as but not limited to depressive disorders, schizophrenia or epilepsy
- •Any other pain condition requiring acute or chronic use of pain medication that cannot be discontinued at screening
- •Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout, pseudo gout, systemic lupus erythematodes, ankylosing spondylitis, mixed connective tissue disease
- •Symptomatic hip OA ipsilateral to the target knee
- •Severe (axial misalignment > 10°), uncorrected genu vara and genu valga
- •Arthroscopy of the target knee within 6 months prior or during the study
研究组 & 干预措施
Test Product
Experimental
2.2 g FLEXISEQ® twice daily
干预措施: FLEXISEQ® (Device)
Placebo
Placebo Comparator
2.2 g placebo twice daily
干预措施: Placebo (Device)
结局指标
主要结局
WOMAC pain score
时间窗: 3 months
Change from baseline to final visit of the average of the WOMAC pain subscale scores
次要结局
- Patient Global Assessment of Change (PGIC)(3 months)
- WOMAC function score(3 months)
- WOMAC stiffness score(3 months)
研究者
研究点 (1)
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