jRCT2031220354进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, Phase III trial to evaluate the efficacy and safety of intra-articular injections of RTX-GRT7039 in adult subjects with pain associated with osteoarthritis of the knee.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •>=18 years of age at the screening visit.
- •Body Mass Index (BMI) <= 40.0 kg/m
- •Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I-III.
- •Moderate to severe osteoarthritis at baseline.
- •Documented history indicating that subject has insufficient pain relief with optimal standard of care (SoC).
- •The investigator does not consider that any additional benefit can reasonably be expected from further adjustments to the patient's pain treatment.
排除标准
- •The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within 3 months.
- •The subject had an injection of platelet-rich plasma into the index knee within 6 months.
- •The subject applied topical capsaicin on the index knee within 3 months.
- •Pre-existing rapidly progressing osteoarthritis (RPOA) Type I or Type II, osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, or the subject has knee pain attributable to disease other than osteoarthritis.
- •Other conditions that could confound discrimination of pain assessment in the index knee.
- •Clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the subject's participation in the full duration of
- •History of severe allergic or anaphylactic reactions.
- •History of significant trauma or surgery, or surgery planned during the trial period, related to the knee.
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score in the index knee
次要结局
- Change in WOMAC pain subscale score in the index knee
- Incidence of treatment-emergent adverse events (TEAEs)
- Incidence of TEAEs representing structural changes of the knee joint
研究者
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