A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 310
- 主要终点
- Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo
研究概览
简要总结
The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).
详细描述
This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee.
Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
- 16 mg FX006,
- 32 mg FX006, or
- normal saline (placebo).
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [Baseline], Weeks 4, 8, 12, 16, 20, and 24).
The study was expected to enroll over approximately 6 to 7 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- •Male or female >=40 years of age
- •Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
- •Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
- •Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
- •Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
- •Body mass index (BMI) ≤ 40 kg/m2
- •Willingness to abstain from use of restricted medications
排除标准
- •Ipsilateral hip OA
- •Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
- •History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
- •History of arthritides due to crystals (e.g., gout, pseudogout)
- •History or clinical signs and symptoms of infection in the index joint
- •Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)
- •Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
- •IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
- •IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- •Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
- •Oral corticosteroids (investigational or marketed) within 1 month of Screening
- •Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- •Any other IA investigational drug/biologic within 6 months of Screening
- •Prior use of FX006
- •Women of child-bearing potential not using effective contraception or who are pregnant or nursing
研究组 & 干预措施
FX006 16 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
干预措施: FX006 16 mg (Drug)
FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
干预措施: FX006 32 mg (Drug)
Placebo
Normal Saline Single 5 mL intra-articular (IA) injection
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo
时间窗: Baseline and Week 12
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain"and 10 indicates "pain as bad as you can imagine."
次要结局
- Change From Baseline to Week 12 for WOMAC C (Function Subscale)(Baseline and Week 12)
- Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)(Baseline and Week 12)
- Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores(Baseline and Weeks 16, 20 and 24)