EUCTR2012-001431-31-BE进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase II trial to investigate the efficacy and safety of 30 mcg and 100 mcg AS902330 given as one cycle of three intra-articular knee injections once a week for three weeks as an adjunct treatment to patients following microfracture surgery for cartilage injury of the knee. - Phase II Trial of AS902330 as Adjunct to Microfracture in Cartilage Injury
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 36
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
- •adults subjects; 18 to 60 years old of either sex with symptomatic knee cartilage injury who are eligible for MFx surgery on the femoral articular surfaces, with intact subchondral bone.
- •Intraoperative inclusion criteria require that there be one or two focal chondral lesions per target knee and that each lesion satisfy all of the following criteria after peripheral debridement to healthy cartilage: (1) area between 1 and 4 cm2 (inclusive), (2) depth = 6 mm, and (3) arthroscopic confirmation that the lesion is a non-osteochondritis dissecans (OCD) lesion between International Cartilage Repair Society (ICRS) grades I and III (D); a grade III non-OCD lesion is equivalent to an Outerbridge grade IV lesion with minimal subchondral bone loss.
- •Subjects must have moderate to severe pain in the target knee prior to surgery, with an average score = 4.0 on the NRS of pain intensity over 7 consecutive days within 30 (+15) days before surgery.
- •Subjects must be willing to comply with postoperative and routine clinical and radiographic evaluations, and to follow a standardized rehabilitation program.
- •Women of childbearing potential must use a form of contraception with a failure rate of less than 1% per year for the first 24 months of the trial. The use of contraception is also recommended throughout the remaining duration of the trial, due to the planned MRI scans involving gadolinium contrast medium (which is contraindicated in case of pregnancy or breastfeeding) and also because of potential confounding effects of pregnancy on symptoms and trial assessments.
- •Written informed consent must be obtained prior to any trial-related activity.
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria include specified previous knee surgeries and procedures, more than two chondral lesions or presence of bipolar (or kissing”) lesions in the target knee, need for concurrent partial meniscectomy, need for any other major concomitant procedure affecting the target knee or for bilateral knee surgery, osteoarthritis in the target knee, body mass index (BMI) > 35 kg/m², malalignment of the target knee of > 5 degrees measured from the mechanical axis, concomitant conditions or treatments that the investigator considers to constitute a risk or contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation, contraindications to MRI scanning, pregnancy or breastfeeding, regular smoking of more than 10 cigarettes or equivalent per day within the past 6 months, participation in another clinical trial within the past 30 days (or 5 half-lives of the investigated compound,whichever is longer), and legal incapacity or limited legal capacity.
研究者
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