NCT02558439已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 24-Week Study to Evaluate the Safety and Efficacy of a Single Injection of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain
Centrexion Therapeutics20 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 20
- 主要终点
- Change from Baseline through Week 12 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 1.0 mg compared to placebo in subjects with osteoarthritis (OA) of the knee
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a single injection of CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiography of both knees with a posterior-anterior, fixed flexion view taken during the Screening period. The index knee must show evidence of chronic OA.
- •Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 2 months prior to Screening, as assessed by the Investigator.
- •A specified mean pain score in the index knee over the 7 days prior to dosing, based on question A1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC A1).
- •Specified baseline and screening scores on the WOMAC A1
- •Body Mass Index ≤ 45 kg/m
- •Subjects must have had a therapeutic failure (no relief, or inadequate relief), and/or AEs resulting in stopping treatment, and/or contraindication to the standard of care appropriate to the severity of the index knee OA pain they are experiencing.
排除标准
- •Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 12 months.
- •Prior arthroscopic surgery of the index knee within 3 months of Screening.
- •Any painful conditions of the index knee due to joint disease other than OA.
- •Mild pain in the non-index knee when walking.
- •Other chronic pain anywhere in the body that requires the use of analgesic medications.
- •Secondary OA of the index knee due to acute traumatic injury.
- •Significant current or past instability (e.g., cruciate ligament tear or rupture or previous repair) or misalignment (> 10 degrees varus or valgus) of the index knee
- •Has used topical capsaicin on the index knee within 90 days of Screening.
- •Corticosteroid injection in the index knee within 90 days of Screening.
- •Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening.
- •Prior participation in an ALGRX 4975 or CNTX-4975 study.
- •Has any of the following characteristics:
- •active or historic substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, or
- •tests positive upon urine drug screen for a substance of abuse.
- •Has moderate to severe depression or anxiety.
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will receive a single injection of placebo into the index knee following local anesthesia and adjunct joint cooling.
干预措施: Placebo (Other)
0.5 mg CNTX-4975
Experimental
Subjects will receive a single injection of 0.5 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
干预措施: CNTX-4975 (Drug)
1.0 mg CNTX-4975
Experimental
Subjects will receive a single injection of 1.0 mg CNTX-4975 into the index knee following local anesthesia and adjunct joint cooling.
干预措施: CNTX-4975 (Drug)
结局指标
主要结局
Change from Baseline through Week 12 in average knee index pain with walking over previous 24 hours using WOMAC A1 question in subjects treated with CNTX-4975 1.0 mg compared to placebo in subjects with osteoarthritis (OA) of the knee
时间窗: At 12 Weeks
次要结局
- Change from Baseline through Week 12 in average index knee pain with walking using WOMAC A1 question in subjects treated with CNTX 0.5 mg compared to placebo(At 12 Weeks)
- Change from Baseline to each study visit through Week 24 in average index knee pain with walking using WOMAC A1 in subjects treated with CNTX-4975 compared to placebo(Up to 24 weeks)
- Change from Baseline through Week 4 in the average index knee pain with walking using the WOMAC A1 question(Up to 4 weeks)
研究者
研究点 (20)
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