A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 329
- 主要终点
- Change in Knee Pain
研究概览
简要总结
This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.
详细描述
A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.
The primary trial objective is to evaluate whether there is greater efficacy of 10 mL Ampion™ versus 10 mL placebo than 4 mL Ampion™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.
The secondary trial objective include: the evaluation of the safety of an intra-articular injection of Ampion™ when applied to patients suffering from OA of the knee, evaluation of the efficacy of intra-articular injection of Ampion™ and placebo on stiffness and function when applied to patients suffering from OA of the knee and evaluation of responder status defined by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) Criteria.
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, Investigator)
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
- •Able to provide written informed consent to participate in the study
- •Willing and able to comply with all study requirements and instructions of the site study staff
- •Male or female, 40 years to 85 years old (inclusive)
- •Must be ambulatory
- •Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of osteoarthritis (OA) and supported by radiological evidence Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening
- •Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at screening
- •Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used)
- •No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure
- •No known clinically significant liver abnormality e.g. cirrhosis, transplant, etc.)
排除标准
- •As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
- •A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
- •A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
- •Presence of tense effusions
- •Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator
- •Isolated patella femoral syndrome, also known as chondromalacia
- •Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial e.g. cancer, congenital defects, spine OA)
- •Major injury to the index knee within the 12 months prior to screening
- •Severe hip OA ipsilateral to the index knee
- •Any pain that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee)
- •Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
- •Use of the following medications:
- •No IA injected pain medications in the study knee during the study
- •No analgesics containing opioids. NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply
- •No topical treatment on osteoarthritis index knee during the study
- •No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
- •No systemic treatments that may interfere with safety or efficacy assessments during the study
- •No immunosuppressants
- •No use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable)
- •Any human albumin treatment in the 3 months before randomization
研究组 & 干预措施
Placebo 4 mL Dose
4 mL Injection of Placebo
干预措施: 4 mL Injection of Placebo (Drug)
Ampion 4 mL Dose
4 mL Injection of Ampion
干预措施: 4 mL injection of Ampion (Biological)
Ampion 10 mL Dose
10 mL Injection of Ampion
干预措施: 10 mL Injection of Ampion (Biological)
Placebo 10 mL Dose
10 mL Injection of Placebo
干预措施: 10 mL Injection of Placebo (Drug)
结局指标
主要结局
Change in Knee Pain
时间窗: Scored at Baseline and 12 weeks
Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.
次要结局
- Change in Knee Function(Scored at Baseline and 12 weeks.)
- Change in Knee Stiffness.(Scored at Baseline and 12 weeks.)
- Change in Patient's Global Assessment(Scored at Baseline and 12 weeks.)