A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 229
- 主要终点
- Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
研究概览
简要总结
The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.
详细描述
Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.
The general tolerability of a single injection of FX006 also was assessed.
Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.
The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.
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
- •Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
- •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
- •Main Exclusion Criteria
- •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 of infection in the index joint
- •Clinical signs and symptoms of active knee infection or crystal disease of the index knee
- •Presence of surgical hardware or other foreign body in the index knee
- •Unstable joint (such as a torn anterior cruciate ligament)
- •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
- •Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
- •Prior arthroscopic or open surgery of the index knee within 12 months of Screening
- •Planned/anticipated surgery of the index knee during the study period
- •Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
- •Insulin-dependent diabetes
- •Active psychiatric disorder including psychosis and major depressive disorder
- •History of or active Cushing's syndrome
- •Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
- •Skin breakdown at the knee where the injection would take place
- •Women of child-bearing potential not using effective contraception or who are pregnant or nursing
排除标准
- 未提供
研究组 & 干预措施
FX006 10 mg
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
干预措施: FX006 (Drug)
FX006 40 mg
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
干预措施: FX006 (Drug)
FX006 60 mg
Single 3mL intra-articular (IA) injection Extended-Release Formulation
干预措施: FX006 (Drug)
TCA IR 40 mg
Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide
干预措施: TCA IR (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
时间窗: 8 weeks
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."
Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
时间窗: 10 weeks
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."
Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
时间窗: 12 weeks
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 Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.(Weeks 1-7 and Week 9 and 11)
- Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8(8 weeks)
- Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.(8 weeks)
- WOMAC A (Pain Subscale) Change From Baseline at Week 8(8 weeks)
- WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8(8 weeks)
- Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8(8 weeks)
- Clinical Global Impression of Change Scores at Week 8(8 weeks)
- Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg(Weeks 8, 10 and 12)
- Percent of Responders According to OMERACT-OARSI Criteria at Week 8(8 weeks)
- WOMAC B (Stiffness Subscale) Change From Baseline at Week 8(8 weeks)
- WOMAC C (Function Subscale) Change From Baseline at Week 8(8 weeks)
- Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8(8 weeks)
- Patient Global Impression of Change Scores at Week 8(Week 8)