An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.
phase 4, open label, multi-center, prospective non-interventional descriptive
Study Type
OBSERVATIONAL
Enrollment
305
Auxilium Investigational Site
Bergen, Norway
Auxilium Investigational Site
Drammen, Norway
Auxilium Investigational Site
Málaga, Andalusia, Spain
Auxilium Investigational Site
Alcorcón, Madrid, Spain
clinical treatment success as assessed by goniometry
Time frame: an expected average of 5 weeks
treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires
Time frame: an expected average of 5 weeks
Treatment option as determined by treating physician in consultation with patient
Time frame: at day 1
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Auxilium Investigational Site
Majadahonda, Madrid, Spain
Auxilium Investigational Site
Pamplona, Navarre, Spain
Auxilium Investigational Site
Valladolid, Spain