NCT01290510已完成不适用
Hyaluronan in the Treatment of Painful Tendinopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2% hyaluronan) in the treatment of painful tendinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 75 years of age and good general health condition.
- •Signed written informed consent.
- •Painful tendinopathy since ≥ 6 weeks.
- •Pain according to Visual Analogue Scale (VAS; 100 millimetres (mm)) ≥ 40 mm.
- •Ensured compliance of subjects for study period.
排除标准
- •Treatment with any investigational product within 4 weeks prior to study entry.
- •Patients with known hypersensitivity to the products (that is active compound and excipients) or any component or procedure used in the study.
- •Severe intercurrent illness (for example: uncontrolled diabetes mellitus, peripheral neuropathy), 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.
- •Concomitant disease at study relevant site influencing study evaluation.
- •List of diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation.
- •List of concomitant medications not allowed.
- •Patients treated with: systemic and/or local steroids within the last 4 weeks, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours.
- •Recent history of drug and/or alcohol abuse (within the last 6 months).
- •List of contra-indications to the treatment.
- •Pregnant or lactating females.
- •Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner during the treatment period and the first 4 weeks follow-up period.
- •Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and or non completion of the study according to investigator's judgement.
结局指标
主要结局
Change from Baseline in Visual Analogue Scale of pain (VAS; 100 millimetres (mm)) on day 35
时间窗: Baseline and Day 35
次要结局
- Visual Analogue Scale of pain (VAS; 100 mm) on day 7(On Day 7)
- Visual Analogue Scale of pain (VAS; 100 mm) on day 90(On Day 90)
- Clinical parameters at baseline(At baseline)
- Clinical parameters on day 7(On Day 7)
- Clinical parameters on day 35(On Day 35)
- Clinical parameters on day 90(On Day 90)
- Quality of life questionnaire at baseline(At baseline)
- Quality of life questionnaire on day 7(On Day 7)
- Quality of life questionnaire on day 35(On Day 35)
- Quality of life questionnaire on day 90(On Day 90)
- Patient's and investigator's global evaluation of study-relevant tendon complaints on day 7(On Day 7)
- Patient's and investigator's global evaluation of study-relevant tendon complaints on day 35(On Day 35)
- Patient's and investigator's global evaluation of study-relevant tendon complaints on day 90(On Day 90)
- Frequency of test product-related Adverse Events(Up to Day 90)
研究者
研究点 (4)
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