A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 368
- 试验地点
- 27
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
研究概览
简要总结
The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.
详细描述
This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.
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, Outcomes Assessor)
盲法说明
Participants and Outcomes Assessor were blinded to treatment
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
- •Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.
排除标准
- •Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
- •Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).
研究组 & 干预措施
Saline
Single injection of 0.9% saline supplied as a 4 milliliter (mL) unit dose in a 5mL glass syringe
干预措施: Saline (Device)
Hyaluronic Acid and TH (Cingal®)
Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe
干预措施: Hyaluronic Acid and TH (Cingal®) (Device)
Hyaluronic Acid (Monovisc®)
Single injection of sodium hyaluronate supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe
干预措施: Hyaluronic Acid (Monovisc®) (Device)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
时间窗: 12 Weeks
The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP)
时间窗: 12 Weeks
The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
次要结局
- OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT)(12 Weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)(3 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)(26 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)(3 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)(3 Weeks)
- Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP)(3 Week)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)(26 Weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP)(26 Weeks)
- Evaluator Global Assessment Comparing Cingal® to Saline (PP)(26 Weeks)
- Evaluator Global Assessment Comparing Cingal® to Saline (ITT)(26 Weeks)
- Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP).(1 Week)
- Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)(3 Week)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)(3 Weeks)
- OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP)(12 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)(26 Weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)(1 Week)
- Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)(12 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)(1 Week)
- Evaluator Global Assessment Comparing Cingal® to Saline (ITT)(12 Weeks)
- Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)(1 Week)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)(1 Week)
- Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)(12 Weeks)
- Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)(1 Week)
- Evaluator Global Assessment Comparing Cingal® to Saline (PP)(12 Weeks)