Post Approval Commitment Study

Completed

• Conditions: Dupuytren's Contracture
• Interventions: Procedure: surgery; Drug: Xiapex

• Registration Number: NCT01444729
• Lead Sponsor: Endo Pharmaceuticals

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 Description

phase 4, open label, multi-center, prospective non-interventional descriptive

Study Timeline

• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-03
• Study Start: 2012-03
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

• Adults with a palpable cord eligible for the treatment of Dupuytren's contracture

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery	surgery	Fasciotomy or fasciectomy
xiapex	Xiapex	Subject treated with Xiapex

Primary Outcome Measures

Name	Time	Method
treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires	an expected average of 5 weeks
clinical treatment success as assessed by goniometry	an expected average of 5 weeks

Secondary Outcome Measures

Name	Time	Method
Treatment option as determined by treating physician in consultation with patient	at day 1

Trial Locations

Locations (1)

Auxilium Investigational Site; 🇪🇸 Valladolid, Spain