A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Intra-Articular Injection of a Solution of High and Low Molecular Weight Sodium Hyaluronate (HL-01) in the Treatment of Pain in Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 704
- 主要终点
- Change from Baseline of the average daily pain intensity score.
研究概览
简要总结
The goal of this clinical trial is to test HL-01 in patients with knee osteoarthritis pain. The main question[s] it aims to answer are:
- Measure the change in average daily knee pain intensity scores from baseline to the end of the study using a pain scale that measures pain on a scale of 0 to 10
- Measure the change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scales measuring knee pain, stiffness, and function from baseline to the end of the study
- Measure the change in EuroQol EQ-5D-5L quality of life assessments from baseline to end of the study
- Measure change of participant and physician assessment of how the target knee pain and function are affected by the condition from baseline to end of the study
- Measure how often rescue medication is taken from baseline to end of the study
- Assess how well participants tolerate the study medication injection (investigational drug or placebo)
- Assess whether there are any adverse reactions or side effects from the study medication injection
Participants will be asked to complete the following:
-
Provide informed consent
-
Knee X-ray of target knee
-
Complete physical health assessments (e.g., target knee assessment, height, weight, physical exam) at several timepoints throughout the study
-
Provide demographic information and their medical/surgical history
-
Provide blood and urine samples at several timepoints throughout the study
-
Injection of study medication (investigational drug or placebo)
-
Complete electronic diaries for the following:
-
Record average daily knee pain intensity scores during screening to confirm eligibility for the study
-
Record average daily knee pain intensity scores after receiving the study medication injection until they complete the study
-
Complete WOMAC scales assessing knee pain, stiffness, and function at baseline, Week 6, Week 12 and/or the end of the study
-
Complete EuroQol EQ-5D-5L quality of life assessments at baseline, Week 6, Week 12 and/or the end of the study
-
Complete global assessment of how the target knee pain and function are affected by the condition at baseline, Week 6, Week 12 and/or the end of the study
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is between 40 and 80 years of age
- •Have symptoms of knee osteoarthritis (OA) for at least 6 months
- •Meet American College of Rheumatology criteria (clinical and radiological) for knee OA
- •Body mass index (BMI) is less than or equal to 40 kg/m2
- •Target knee x-ray grade Kellgren-Lawerence (KL) grade 2 or 3
- •Have failed at least one prior conservative therapy for knee OA in last 12 months, which includes physical therapy, NSAIDs, and other pain medications
- •The knee pain scores during screening and baseline must meet specified qualifying criteria for both the target and the contralateral (non-target) knees
- •Willing to complete all electronic diaries and only use study-provided acetaminophen for pain management while participating in the study
- •Have negative pregnancy tests during Screening and prior to injection and will not be pregnant or nursing or plan to be pregnant while participating in the study
- •Must use a highly effective birth control method if sexually active
排除标准
- •Have taken or had any prohibited medications, supplements, or therapies that could have an influence on study assessments. Some may be permitted with stable dose or after stopping for a period of time. Please refer to physician for further details.
- •Have active infections or target knee conditions that may compromise study drug administration
- •Have exclusionary lab values determined during Screening
- •Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee
- •Have or had primarily patellofemoral OA, severe malalignment, certain knee surgeries, or other excluded target knee conditions
- •Have joint disorders, uncontrolled fibromyalgia, or clinically significant conditions that could interfere with study assessments or compromise participant safety
- •Received another clinical trial therapy, medication, or product with 90 days of Screening
- •Have non-compliance with study diaries during Screening
- •Involved in litigation, disability, or worker's compensation matters based on OA pain
- •Allergic to study drug, HA, placebo, or acetaminophen
研究组 & 干预措施
High and Low Molecular Weight Sodium Hyaluronate (HL-01)
Patients will receive single intra-articular knee injection of 3.36% HL-01.
干预措施: Sodium hyaluronate solution - 3.36% (Drug)
Sterile buffered solution
Patients randomized to placebo will receive single intra-articular knee injection of 3.36% sterile buffered solution (sodium chloride).
干预措施: Sterile buffered solution (Drug)
结局指标
主要结局
Change from Baseline of the average daily pain intensity score.
时间窗: From Baseline to Week 12
The average daily (24 hour) pain intensity score will be measured on a numeric rating scale (NRS) ranging from 0 to 10. The Baseline value will be the mean of the daily records over the 7-day period before Day 1.
次要结局
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline to Week 12.)