A Phase Ib/II, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of LG00034053 Administered by Intra-articular Injection in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point
研究概览
简要总结
This study is a multi-center, randomized, placebo-controlled, double-blind clinical study, consisting of Part 1 (Phase 1b) in a sequential, dose-escalating design and Part 2 (Phase 2) in a parallel design.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Patients diagnosed with primary osteoarthritis of the knee according to the ACR clinical criteria, with Kellgren-Lawrence grade 2 to 3 in the corresponding knee as determined in the X-ray test
- •Patients with pain in the index knee requiring NSAIDs or analgesics which sustained for at least 6 months
- •Patients with a score of ≥ 4 and ≤ 9 in response to question 1 (walking pain) on the WOMAC pain subscale (11-point NRS)
- •Patients with the subtotal score of ≥ 20 and ≤ 45 on the WOMAC pain subscale (11- point NRS)
- •Patients with BMI at or below 40 kg/m2
排除标准
- •Patients with chronic pain requiring continuous treatment
- •Patients with rheumatoid arthritis or other inflammatory arthritis
- •Patients with skin disorders at the administration site
- •Patients with clinically significant renal or cardiovascular disease or those with suspected SARS-CoV-2 infection
- •Patients in a medical condition which may affect the efficacy and/or safety assessment
- •Patients with Kellgren-Lawrence grade 4 in the contralateral knee
- •Patients with tense effusion
- •Patients having administered an opioid analgesic/ other analgesic/health functional foods, single dose of IA injection within a certain period prior to drug administration
- •Patients having undergone knee replacement
研究组 & 干预措施
LG00034053
White to slightly brown powder, dosage (6mg, 15mg, 45mg; dose escalation design), single dose administration
干预措施: LG00034053 (Drug)
Placebo
Clear liquid, single dose administration
干预措施: LG00034053 (Drug)
结局指标
主要结局
Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point
时间窗: week 12
Change of WOMAC (11-point NRS) pain score from baseline to Week 12 - a total of 5 questions, each question's score is as below Mininum : 0 (no pain) Maximum : 10 (extreme pain) Higher score means worse outcome
次要结局
- Change in WOMAC score from baseline to time point(week 1 ~ week 24)
- Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point(week 1 ~ week 24)