EUCTR2018-000818-37-HR进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, single dose phase IIb exploratory study to document the clinical effects and safety of intra-articular injections of Lopain (MTX-071) in patients with chronic osteoarthritic knee joint pain (Part 1 and Part 3)with exploratory pharmacokinetics (Part 3) and of higher doses orconsecutive administrations with local anesthetics with exploratorypharmacokinetics (Part 2).
Mestex AG0 个研究点目标入组 156 人开始时间: 2019年5月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent
- •Otherwise healthy (or with stable medical conditions) men or women
- •with knee osteoarthritis aged between 40 and 80 years (extremes
- •At least 40 mm on motion on the 100 mm-VAS (Visual Analog Scale) for
- •average osteoarthritic joint pain in the target knee during the last 2
- •days, with or without pain medication.
- •Only for Part 3: Documented history indicating that subject had
- •insufficient pain relief and was unsatisfied with optimized Standard of
- •a. non-pharmacological treatment, and
- •b. treatment with oral or topical NSAIDS, and
- •c. intra-articular treatment with corticosteroids,
- •d. and where appropriate intra-articular treatment with hyaluronic acid
- •and/or opioids in combination or as monotherapies,
- •or subject is unable to take Standard of Care due to contraindication or
- •intolerability. If this refers only to one of the Standard of Care
- •treatments the criterion above applies for the other treatment options.
- •Previous assessment (e.g. radiography, MRI or arthroscopy, not older
- •than 3 years) showing a Kellgren Lawrence Grade of 2 – 4.
- •Female patients are only eligible for the study if they are either
- •surgically sterile or at least 2 years postmenopausal.
- •Sexually active male patients must agree to use a reliable contraceptive
- •method for at least one month after the injection of MTX-071/Placebo.
- •Patient is highly likely to comply with the protocol and complete the
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 104
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •Previous exposure to the study drug of the target knee.
- •Any contra-indication as per summary of product characteristics for the
- •premedication used.
- •Surgery of the target knee within 6 months before study start or
- •planned surgery for any time during the next 6 months.
- •Any injection into the target knee within the previous month or trauma
- •to the knee not yet healed.
- •Only for Part 3: The subject is not able to clearly identify the target
- •knee (i.e. the more painful knee)
- •History of uncontrolled (at the discretion of the investigator)
- •cardiovascular, renal, and/or other disease or malignancy.
- •History of severe allergic or anaphylactic reactions.
- •Male patients whose partner is planning to receive a child
- •Major bleeding disorder encompassing, but not limited to coagulopathy
- •and any current antithrombotic and anticoagulant events. Low dose
- •acetylsalicylic acid for cardiovascular prevention can be allowed in
- •consultation with the medical monitor.
- •Clinically significant (at the discretion of the investigator) deviation
- •from the normal laboratory values.
- •Clinically significant (at the discretion of the investigator) abnormal
- •History of drug/chemical/substance/alcohol abuse within the past 2
- •years prior to Screening.
- •Significant (at the discretion of the investigator) symptomatic, viral,
- •bacterial (including upper respiratory infection), or fungal (noncutaneous)
- •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).
- •Patients who had a corticosteroid or hyaluronic acid injection in the
- •target knee within 3 months prior to Baseline or are planned to get a
- •corticosteroid injection within 6 months (Part 1, Part 2 and Part 3), any
- •other such injection within 3 months (Part 1 and Part 2 only) following
- •the injection of MTX-071/placebo or any other such injection within 6
- •months (Part 3 only) following the first injection of MTX-071/placebo.
- •Systemic (except inhaled) 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 patient's participation in the trial.
- •Patients who are dependent on the sponsor or investigator
研究者
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