A Double-Blind, Randomized, Single-Dose 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
- 3 期
- 状态
- 已完成
- 入组人数
- 486
- 试验地点
- 2
- 主要终点
- Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) 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 safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
详细描述
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
- 32 mg FX006,
- normal saline (placebo), or
- 40 mg TCA IR.
Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to <6, 6 to <7, and ≥7.
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 in approximately 6 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 symptoms associated with OA of the index knee for 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
- •Index knee pain for > 15 days over the last month
- •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
- •Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, 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 or greater than the index knee pain)
- •Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
- •History of infection in the index knee
- •Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- •Unstable joint within 12 months of screening
- •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) or oral corticosteroids (investigational or marketed) within 1 month 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 32mg
Single 5 mL intra-articular (IA) injection Extended-release Formulation
干预措施: FX006 (Drug)
Normal Saline
Single 5 mL intra-articular (IA) injection
干预措施: Placebo (Drug)
TCA IR 40 mg
Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation
干预措施: TCA IR 40 (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 (ADP) Intensity Scores for 32 mg FX006 Versus Placebo
时间窗: Baseline and 12 Weeks
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
次要结局
- Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo(Baseline to 12 Weeks)
- AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR(Baseline to 12 Weeks)
- Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR(Baseline through 12 Weeks)
- AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo(Baseline to 24 Weeks)