Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Change of Pain Over 26 Weeks (Change From Baseline)
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.
详细描述
To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject (female or male)
- •40-85 years of age
- •Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for diagnosis of osteoarthritis(OA)
- •Radiographic evidence of OA in the study knee
- •WOMAC pain score of 7-17 in the study knee
- •WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)
- •Subject normally active
- •Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies)and to simple analgetics
- •Subject cooperative and able to communicate effectively with the investigators
- •Body mass index ≤ 35 kg/m2;
- •Signed informed consent obtained
排除标准
- •Knee effusion
- •Contralateral knee OA
- •Clinically significant joint pain from joints other than the knee
- •Previous intra-articular steroid injection into the study knee within the last 6 months
- •Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the last 9 months
- •Previous allergic type reaction to a HA product
- •Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit
- •Use of analgesics 48 hours preceding the baseline visit
- •Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months
- •Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
- •Change in physical therapy for the knee within the last three months
- •Arthroscopy or other surgical procedure in the study knee within the past 12 months
- •Serious injuries to the study knee in the past
- •Any planned arthroscopy or other surgical procedure during the study period
- •Previous history or presence of active septic arthritis
- •Active skin disease or infection in the area of the injection site
- •Systemic active inflammatory condition or infection
- •Bleeding diathesis or use of anticoagulants
- •History of drug or alcohol abuse within 6 months
- •Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
- •Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception
- •Involvement in other clinical trials
研究组 & 干预措施
Durolane 3ml
Durolane 3 ml is an Intraarticular hyaluronic acid
干预措施: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml (Device)
Durolane 4.5
Durolane 4.5 is an Intraarticular hyaluronic acid
干预措施: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml (Device)
Durolane 6 ml
Durolane 6 ml is an Intraarticular hyaluronic acid
干预措施: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml (Device)
结局指标
主要结局
Change of Pain Over 26 Weeks (Change From Baseline)
时间窗: 26 weeks after treatment compared to baseline
The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions. It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.
次要结局
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.(From baseline to 26 weeks after treatment)
- WOMAC Stiffness Score (Change From Baseline)(26 weeks after treatment compared to baseline)
- WOMAC Physical Function Score (Change From Baseline)(26 weeks after treatment compared to baseline)
- Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)(26 weeks after treatment compared to baseline)