NCT03429049已完成3 期
A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
Centrexion Therapeutics33 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2018年1月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 33
- 主要终点
- Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
研究概览
简要总结
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study-provided tablet computers.
- •Confirmation of osteoarthritis (OA) of the knee.
- •Confirmation of OA of the index knee.
- •Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
- •BMI ≤45 kg/m^
- •Must have failed 2 or more prior therapies.
- •Females not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile, or practicing one of the following medically acceptable methods of birth control throughout the study period.
- •Subject agrees to stay on their current pain medication (including over the counter (OTC) medications) from the time of Screening through Week
- •The current pain medication must be taken only for pain in the index knee, and not for another pain indication.
- •Subject agrees to take only the allowed rescue medications for OA knee pain of the index knee from the time of Screening through study completion and agrees to use no topical medications for OA knee pain during the trial.
排除标准
- •Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.
- •Prior arthroscopic surgery of the index knee within 6 months of Screening.
- •Any painful conditions of the index knee due to joint disease other than OA.
- •Periarticular pain from any cause.
- •Pain in the non-index knee that is >3 on a numeric pain rating scale (NPRS) (0-10) when walking or at rest.
- •Other chronic pain anywhere in the body that requires the use of analgesic medications.
- •Instability of the index knee.
- •Misalignment (>10 degrees varus or valgus) of the index knee on standing.
- •Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.
- •Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.
- •Plans to have surgery, other invasive procedures, or IA injections while participating in the study.
- •Has used topical capsaicin on the index knee within 90 days of Screening.
- •Current use of opioids for any condition other than for OA of the index knee.
- •Corticosteroid injection into the index knee within 90 days of Screening.
- •Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo of 2.0 mL for IA injection
干预措施: Placebo (Drug)
CNTX-4975-05
Experimental
Pre-filled glass syringes administered as a single 2.0 mL IA injection
干预措施: CNTX-4975-05 (Drug)
结局指标
主要结局
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
时间窗: Baseline, Week 12
Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score. Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.
次要结局
- Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score(Baseline, Week 12)
- Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score(Baseline, Week 12)
- Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score(Baseline, Week 12)
研究者
研究点 (33)
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