A Randomized, Double-blind, Placebo-controlled, Phase III Trial, to Evaluate the Efficacy and Safety of a Single Intra-articular Injection of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 466
- 试验地点
- 81
- 主要终点
- Least Squares Mean (Standard Error) [LS-mean (SE) ] Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 12
研究概览
简要总结
A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of single injection of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.
详细描述
This trial comprises a total observation period of up to 52 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has given written informed consent to participate.
- •The participant is 18 years of age or older at the Screening Visit.
- •The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
- •There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.
排除标准
- •The participant has past joint replacement surgery of the index knee.
- •The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
- •The participant has periarticular pain from any cause other than osteoarthritis, including referred pain, bursitis, or tendonitis.
- •The participant has clinical hip osteoarthritis on the side of the index knee.
- •The participant has pre-existing osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to disease other than osteoarthritis, or the participant has rapidly progressing osteoarthritis (RPOA) Type I or Type II.
- •The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus >10, valgus >10) by X-ray as assessed by independent Central Readers at Screening Visit.
- •The participant has other conditions that could affect trial endpoint assessments of the index knee.
- •The participant has current 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 participant's participation in the full duration of the trial.
- •The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
- •The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.
- •The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.
研究组 & 干预措施
Placebo
Participants will receive a intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.
干预措施: Placebo (Drug)
RTX-GRT7039
Participants will receive a intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
干预措施: RTX-GRT7039 (Drug)
结局指标
主要结局
Least Squares Mean (Standard Error) [LS-mean (SE) ] Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 12
时间窗: From Baseline up to Week 12
Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine). The scores are averaged over the number of questions.
次要结局
- LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26(From Baseline up to Week 26)
- LS-mean Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 and Week 26(From Baseline up to Week 12 and Week 26)