EUCTR2012-005357-23-IT进行中（未招募）不适用
Preventing injection pain by Clostridium Histolyticum Collagenase Administration for teatment of Dupuytrens contracture - relieve pain for dupuitren cord by EMLA
AUSL VITERBO0 个研究点开始时间: 2013年1月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •At least 18 years of age and 75 years. ;
- •Patient naive to Xiapex injection. ;
- •Presenting with a Dupuytren s contracture of at least 20 degr caused by a palpable ;
- •cord in at least one finger other than the thumb. ;
- •In good health, based upon the results of a medical history, physical examination, ;
- •and safety laboratory profile. ;
- •Female subjects of child bearing potential must use a highly effective ;
- •contraception method or be surgically sterilized or be a post menopausal female ;
- •(i.e., no menses for at least 1 year). A pregnancy test could be performed prior to ;
- •enrollment in the study. ;
- •Evidence of a personally signed and dated informed consent document indicating ;
- •that the subject (or a legally acceptable representative) has been informed of all ;
- •pertinent aspects of the study. ;
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, ;
- •laboratory tests, and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Patients who have known anaphylactic hypersensitivity to the anaesthetics of the ;
- •amide type or any of the components of EMLA cream. ;
- •Patients who are pregnant or breast feeding. ;
- •Patient with glucose-6-phosphate dehydrogenase deficiency or congenital/ ;
- •acquired methaemoglobinaemia. ;
- •Patient with open wounds, infections, atopic dermatitis, skin rashes or cuts at, or ;
- •near, the area where it is needed to apply EMLA Cream. ;
- •Patients with a chronic pain diagnosis. ;
- •Patient with severe kidney or liver disease. ;
- •On an investigational drug within 30 days prior to the first dose of study drug. ;
- •Received a treatment on the selected joint, within 90 days of enrolment in the ;
- •study, for Dupuytren s contracture including needle aponeurotomy or any surgical ;
- •procedure. ;
- •Patients with a known systemic hypersensitivity to collagenase or any of the other ;
- •product excipients. ;
- •On anticoagulant medication or has received anticoagulant medication (except ;
- •aspirin less than 150 mg daily) within 7 days before the first injection. ;
- •Has any clinically significant medical history or condition(s), including conditions ;
- •that affect the hands, that would, in the opinion of the investigator, substantially ;
- •increase the risk associated with the subject s participation in the protocol or ;
- •compromise the scientific objectives of the study. ;
- •Has a chronic muscular, neurological, or neuromuscular disorder that affects the ;
- •Other severe acute or chronic medical or psychiatric condition or laboratory ;
- •abnormality that may increase the risk associated with study participation or ;
- •investigational product administration or may interfere with the interpretation of ;
- •study results and, in the judgement of the investigator, would make the subject ;
- •inappropriate for entry into this study. ;
- •Has jewellery on the hand to be treated that cannot be removed.
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