NCT01291914已完成1 期
A Double-Blind, Randomized,Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 for the Treatment of Pain in Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Change from baseline in the WOMAC A score (pain subscale)
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.
详细描述
The objectives of the study are to assess FX005, as compared to placebo control, for:
- Safety and tolerability
- Analgesic effect
- Pharmacokinetics
Analgesic effect will be assessed using the Western Ontario & McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.
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
- •Male or female ≥40 years of age
- •Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
- •Kellgren-Lawrence grades II or III
- •Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
- •Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
- •Body mass index ≤ 40 kg/m2
- •Willingness to abstain from use of restricted medications during the study
- •Willingness and ability to comply with the study procedures and visit schedule
排除标准
- •Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
- •Clinically apparent tense effusion in index knee
- •Presence of surgical hardware or other foreign body in the index knee
- •Clinical signs and symptoms of active knee infection or crystal disease
- •Intra-articular corticosteroid within 3 months of Screening
- •Intra-articular hyaluronic acid within 6 months of Screening
- •Other intra-articular therapy within 3 months 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
- •History of malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
- •Skin breakdown at the knee where the injection would take place
- •Women who are pregnant, nursing or likely to become pregnant during the time of the study
- •Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception
研究组 & 干预措施
FX005
Experimental
干预措施: FX005 (Drug)
Placebo 1 (Carrier)
Placebo Comparator
干预措施: Placebo 1 (Carrier) (Drug)
Placebo 2 (Diluent)
Placebo Comparator
干预措施: Placebo 2 (Diluent) (Drug)
结局指标
主要结局
Change from baseline in the WOMAC A score (pain subscale)
时间窗: at 4 weeks post treatment
次要结局
- Change from baseline for WOMAC A1 response (pain on walking)(over 4, 8 and 12 weeks post treatment)
- Average weekly consumption of analgesic medications(over 12 weeks post treatment)
- Incidence of treatment emergent adverse events(up to 12 weeks post treatment)
- Change from baseline in WOMAC A score (pain subscale)(over 4, 8 and 12 weeks post treatment)
- Change from baseline for ICOAP constant pain score(at 2, 4, 8 and 12 weeks post treatment)
- Change in patient's global assessment score(at 4, 8 and 12 weeks post treatment)
- Change from baseline for ICOAP total score(at 2, 4, 8 and 12 weeks post treatment)
- Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria(at 4, 8 and 12 weeks post treatment)
- Change in clinical observer's global assessment score(at 4, 8 and 12 weeks post treatment)
- Change from baseline for WOMAC A score (pain subscale)(at 2, 8 and 12 weeks post treatment)
- Change from baseline for WOMAC B score (stiffness subscale)(at 2, 4, 8 and 12 weeks post treatment)
- Change from baseline for WOMAC C score (function subscale)(at 2, 4, 8 and 12 weeks post treatment)
- Change from baseline for WOMAC total score(at 2, 4, 8 and 12 weeks post treatment)
- Change from baseline for ICOAP intermittent pain score(at 2, 4, 8 and 12 weeks post treatment)
研究者
相似试验
已完成
2 期
Study of FX006 in Patients With Osteoarthritis of the KneeOsteoarthritis of the KneeNCT01487161Pacira Pharmaceuticals, Inc229
已完成
2 期
Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the KneeOsteoarthritis of the KneeNCT01487200Pacira Pharmaceuticals, Inc24
已完成
1 期
Phase 1 Study of XAF5 Gel Applied to Skin of Healthy VolunteersHealthyNCT01723241Topokine Therapeutics, Inc.32
终止
2 期
Evaluation of FDY-5301 in Major Trauma Patients in ICUICU Acquired WeaknessNCT04430283Faraday Pharmaceuticals, Inc.8
已完成
2 期
Gemcitabine (GFF) in Patients With Pancreatic CancerMetastatic Pancreatic CancerNCT00919282CONKO-Studiengruppe78