A prospective clinical study on the efficacy of collagenase clostridium histolyticum (CCH) injections in the thumb and first web space contractures in Dupuytren's Disease - The efficacy of CCH in the thumb and first webspace in Dupuytren's Disease

niversity Medical Centre Groningen0 个研究点开始时间: 2012年5月22日最近更新: 2012年7月17日

适应症

试验速览

暂无简介。

•At least 18 years of age and = 75 years.
•Presenting with a Dupuytren’s contracture at MCPJ of thumb of at least 20° caused by a palpable cord, or any adduction contracture of the thumb with palpable cords in first web space.
•In good health, based upon the results of a medical history and physical examination.
•Female patients of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (i.e. no menses for at least 1 year). A pregnancy test will be performed prior to enrolment in the study in fertile women.
•Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Nursing or pregnant, or planning to become pregnant during the treatment phase.
•On an investigational drug within 30 days prior to the first dose of CCH.
•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 150mg 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 hands.
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 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.

发起方

niversity Medical Centre Groningen