NCT02556710已完成3 期
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluated the Efficacy and Safety of an Intra-Articular Injection of AMPION™ in Adults With Pain Due to Osteoarthritis of 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
- 480
- 试验地点
- 1
- 主要终点
- Change in Knee Pain
研究概览
简要总结
This study will evaluate the efficacy and safety of an 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 An Intra-Articular Injection Of AMPION™ In Adults With Pain Due to Osteoarthritis Of The Knee
The primary trial objective is to evaluate the efficacy of 4 mL of 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 is evaluation of the safety of an intra-articular injection of AMPION™.
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 OA and supported by radiological evidence (Kellgren Lawrence Grade II, III, or IV) read by a central reader;
- •WOMAC 5-point Likert pain subscale <1.5 in the contralateral knee;
- •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);
- •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);
- •Ability to discontinue NSAID use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study (low dose Aspirin is allowed during the study);
- •No analgesia (including acetaminophen [paracetamol]) taken 24 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 osteoarthritis)
- •Major injury to the index knee within the 12 months prior to screening
- •Severe hip osteoarthritis 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
- •Pregnancy or planning to become pregnant during the study.
- •Use of the following medications:
- •No IA injected pain medications in the study knee during the study
- •No analgesics containing opioids.
- •NSAIDs are not permitted during the study; 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 low dose 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
- •No human albumin treatment in the 3 months before randomization or throughout the duration of the study
研究组 & 干预措施
Placebo 4 mL dose
Placebo Comparator
4 mL Injection of Placebo
干预措施: 4 mL injection of Placebo (Drug)
AMPION™ 4 mL dose
Experimental
4 mL injection of Ampion
干预措施: 4 mL injection of AMPION™ (Biological)
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)
研究者
研究点 (1)
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