A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Three Intra-articular Injections of Ampion™ (4 mL) Administered Two Weeks Apart in Adults With Pain Due to Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 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 of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.
详细描述
A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis of the knee.
The primary study objective was to evaluate the efficacy and safety from Baseline to Week 20 of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK).
The secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20.
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 (x-ray) acquired at screening and assessed by a central reader. Subjects must have a Kellgren Lawrence Grade of III or IV for inclusion in the study.
- •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 and confirmed at randomization.
- •Moderate to moderately-severe OA pain in the index knee (even if chronic doses of non-steroidal anti-inflammatory drug [NSAID], which have not changed in the 4 weeks prior to screening, have been/are being used).
- •No analgesia taken 24 hours before efficacy measure.
排除标准
- •As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
- •Previous Ampion™ injection in the index knee.
- •Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc).
- •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 in the index knee.
- •Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the index knee, as assessed locally by the Principal Investigator.
- •Isolated patella femoral syndrome, also known as chondromalacia, in the index knee.
- •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 treatment or likely to be changed during the duration of the study.
- •Use of the following medications are exclusionary:
- •IA injected pain medications in the study knee during the study;
- •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;
- •Topical treatment on osteoarthritis index knee during the study;
- •Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed);
- •Systemic treatments that may interfere with safety or efficacy assessments during the study;
- •Immunosuppressants;
- •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
Ampion 4ml dose
4 mL intra-articular injection of Ampion
干预措施: 4 mL injection of Ampion (Biological)
Placebo Solution
4 mL placebo intra-articular injection
干预措施: 4 mL Injection of Placebo (Drug)
结局指标
主要结局
Change in Knee Pain
时间窗: Scored at Baseline and 20 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 20 Weeks)