Prospective Open-label Investigation of the Non-surgical Treatment withcollagenase clostridium histolyticum Xiapex® (X)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

Subject eligibility should be reviewed and documented by an
appropriately qualified member of the investigator's study team before
subjects are included in the study. Subjects must meet all of the
following criteria to enter the study:
1. At least 18 years of age and = 70 years.
2. Presenting with a Dupuytren's contracture of at least 20 degrees
caused by a palpable cord in at least one finger other than the thumb.
3. Positive table top test defined as the inability to simultaneously
place the affected finger(s) and palm flat against a table top.
4. In good health, based upon the results of a medical history, physical
examination, and safety laboratory profile.
5. Female subjects of child bearing potential must use a highly effective
contraception method or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study.
6. 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.
7. 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

Subjects presenting with any of the following will not be included in the
study:
1. Nursing or pregnant, or plan to become pregnant during the treatment phase.
2. On an investigational drug within 30 days prior to the first dose of
study drug.
3. Received a treatment on the selected joint, within 90 days of
enrollment in the study, for Dupuytren's contracture including needle
aponeurotomy or any surgical procedure.
4. Patients with a known systemic hypersensitivity to collagenase or any
of the other product excipients.
5. On anticoagulant medication or has received anticoagulant medication
(except aspirin less than 150 mg daily) within 7 days before the first
injection.
6. 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.
7. Has a chronic muscular, neurological, or neuromuscular disorder that
affects the hands.
8. 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 judgment of the
investigator, would make the subject inappropriate for entry into this
study.
9. Has jewelry on the hand to be treated that cannot be removed.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials