NCT02566564已完成1 期
An Open Label, Single Dose, Dose-escalating Phase I/IIa Study to Determine the Safety and Clinical Effects of Intra-articular Injections of Lopain (MTX-071) in Patients With Chronic Osteoarthritic Knee Joint Pain
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
- 23
- 试验地点
- 1
- 主要终点
- Intensity and severity of AES/SAEs potentially causally related with the study medication
研究概览
简要总结
Phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.
详细描述
Open label, single-dose, dose-escalating phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Written informed consent
- •Men or women aged between 40 and 70 years
- •At least 40 mm on motion and at least 10 mm at rest on the 100 mm-VAS (Visual Analog Scale) for average arthritic joint pain in the knee to be studied during the last 2 days, with or without pain medication.
- •Previously documented radiography showing a Kellgren Lawrence Grade 2 - 4 severity.
- •Female patients of childbearing potential or female partners of childbearing potential of male patients must agree to use a reliable contraceptive method for at least one month after the injection of MTX-
- •Subject is highly likely to comply with the protocol and complete the study.
排除标准
- •Knee surgery within 6 months before study start or planned for any time during the next 6 months.
- •Any injection into the knee to be studied within the preceding 7 days or trauma to the knee not yet healed.
- •History of any clinically significant cardiac, renal, and/or other relevant disease or malignancy.
- •History of severe allergic or anaphylactic reactions.
- •Pregnancy.
- •Major bleeding disorder.
- •Clinically significant deviation from the normal laboratory values.
- •Clinically significant abnormal ECG
- •History of clinically relevant drug/chemical/ substance/alcohol abuse within the past 2 years prior to screening.
- •Symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration.
- •Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg), tuberculosis.
- •Patients who had a corticosteroid injection in the knee to be studied within 3 months prior to baseline or are planned to get a corticosteroid injection within 4 weeks following the injection of MTX-
- •Vaccination within 60 days prior to study medication administration.
- •Systemic immunosuppressant agent within 6 months prior to study medication administration
- •Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
- •Any other condition, which in the opinion of the investigator, precludes the subject's participation in the trial.
- •Patients who are dependent on the sponsor or investigator.
研究组 & 干预措施
open label, single arm
Experimental
Open label, single arm, dose escalating
干预措施: Lopain (Drug)
结局指标
主要结局
Intensity and severity of AES/SAEs potentially causally related with the study medication
时间窗: up to 6 months
overall and per dose level (descriptive statistics) incidence, intensity and severity of AES/SAEs potentially causally related with the study medication
次要结局
- Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)(up to 6 months)
- duration of pain relief response: overall and dose response(up to 6 months)
- pain relief response: overall and dose response(up to 6 months)
- Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores)(up to 6 months)
研究者
研究点 (1)
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