Clinical Trial: Post Approval Commitment Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture
Brief Summary: 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.
Detailed Summary: phase 4, open label, multi-center, prospective non-interventional descriptive
Sponsor: Endo Pharmaceuticals
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Treatment option as determined by treating physician in consultation with patient [ Time Frame: at day 1 ]
Original Secondary Outcome: Same as current
Information By: Endo Pharmaceuticals
Dates:
Date Received: September 8, 2011
Date Started: March 2012
Date Completion:
Last Updated: June 17, 2016
Last Verified: June 2016
