A Pilot Study of a Dexamethasone Implant System in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement.
详细描述
The objectives of the study are to assess the dexamethasone delivery system for:
- Safety and tolerability
- Efficacy
Formal statistical analysis to compare treatment groups will not be performed due to the small number of participants in this pilot study. Summary statistics will be assessed using the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and questionnaires to assess pain intensity, pain medication consumption and wound assessment.
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
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
- •History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis
- •Hemophilia
- •Achondroplasia
- •History of infection in the index joint
- •Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening
- •Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening
- •Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening
- •Prior arthroscopic or open surgery of the index knee within 12 months of screening
- •Planned / anticipated surgery of the index knee during the study period
- •Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
- •Insulin dependent diabetes
- •History of or active Cushing's syndrome
- •Skin breakdown at index knee where procedure would take place
- •Women of child-bearing potential
- •Case history related to motor vehicle accident or workers compensation
- •Presence of hardware in the index knee (e.g. screws, plates)
- •Immunocompromised patients (TB, HIV, etc.)
- •Allergic reactions to acetaminophen and paracetamol
研究组 & 干预措施
Dexamethasone delivery system
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: Through 24 weeks
Change from baseline in weekly mean of the pain intensity score
时间窗: Weeks 12, 24
Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night
次要结局
- Change from baseline in KOOS-JR score (stiffness)(Over 1, 2, 4, 8, 12, 24 weeks post treatment)
- Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria(Weeks 1, 2, 4, 8, 12, 24)
- Average weekly consumption of rescue medications(Through 24 weeks)
- Change from baseline in KOOS-JR score (pain)(Over 1, 2, 4, 8, 12, 24 weeks post treatment)
- Change in patient's global impression of scores assessed via office visits(Weeks 4, 12, 24)
- Average total consumption of rescue medications(Through 24 weeks)
- Change from baseline in weekly mean of the pain intensity score(Weekly through 24 weeks)
- Time of onset of pain relief(Weekly through 24 weeks)
- Change in clinical observer's global impression of scores assessed via office visits(Weeks 4, 12, 24)
- Change from baseline in KOOS-JR score (function)(Over 1, 2, 4, 8, 12, 24 weeks post treatment)
研究者
Mark Figgie
Chief of the Surgical Arthritis Service
Hospital for Special Surgery, New York