NCT02022930已完成3 期
A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 510
- 主要终点
- Change from baseline in the WOMAC A subscale score for the treatment knee.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.
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
- Quadruple (Participant, Care Provider, 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
- •Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
- •Symptoms in the index knee for at least 12 months.
- •Fully ambulatory Subject (ability to perform a 15 meters walk test).
- •Male and female Subjects 40 through 85 years of age.
排除标准
- •BMI >40 kg
- •Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
- •Intra articular steroid therapy in last 3 months
- •Intra articular viscosupplementation in last 6 months
研究组 & 干预措施
Hydros
Experimental
Hydros Joint Therapy
干预措施: Hydros (Device)
Hydros-TA
Experimental
Hydros-TA Joint Therapy
干预措施: Hydros-TA (Device)
Triamcinolone acetonide
Active Comparator
Triamcinolone acetonide
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Change from baseline in the WOMAC A subscale score for the treatment knee.
时间窗: 2 weeks and 26 weeks
次要结局
- Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee(26 weeks)
研究者
相似试验
已完成
2 期
Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)Osteoarthritis of the KneeNCT01134406Carbylan Therapeutics, Inc.98
已完成
2 期
Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨Cutaneous LeishmaniasisNCT02687971Drugs for Neglected Diseases130
已完成
2 期
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver FibrosisNon-alcoholic Steatohepatitis (NASH)NCT03517540Novartis Pharmaceuticals193
已完成
3 期
TAASS-Traumeel Ointment and Gel Compared With a Topical NSAID in Athletes With Acute Ankle SprainSprain of AnkleNCT01066520Biologische Heilmittel Heel GmbH449
已完成
3 期
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisNCT02065557AbbVie101