Post Approval Commitment Study
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ClinicalTrials.gov Identifier: NCT01444729 |
Recruitment Status
:
Completed
First Posted
: October 3, 2011
Last Update Posted
: October 26, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Dupuytren's Contracture | Drug: Xiapex Procedure: surgery |
Study Type : | Observational |
Actual Enrollment : | 305 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2015 |

Group/Cohort | Intervention/treatment |
---|---|
xiapex
Subject treated with Xiapex
|
Drug: Xiapex
Xiapex administration will follow SMPC
|
Surgery
Fasciotomy or fasciectomy
|
Procedure: surgery
Non-pharmacological treatment
|
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults with a palpable cord eligible for the treatment of Dupuytren's contracture
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444729
Norway | |
Auxilium Investigational Site | |
Bergen, Norway, 5021 | |
Auxilium Investigational Site | |
Drammen, Norway, 3004 | |
Spain | |
Auxilium Investigational Site | |
Malaga, Andalucia, Spain, 29010 | |
Auxilium Investigational Site | |
Alcorcon, Madrid, Spain, 28922 | |
Auxilium Investigational Site | |
Majadahonda, Madrid, Spain, 28222 | |
Auxilium Investigational Site | |
Pamplona, Navarra, Spain, 31008 | |
Auxilium Investigational Site | |
Valladolid, Spain, 46011 |
Study Director: | Veronica Urdaneta | Endo |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01444729 History of Changes |
Other Study ID Numbers: |
B1531005 |
First Posted: | October 3, 2011 Key Record Dates |
Last Update Posted: | October 26, 2017 |
Last Verified: | October 2017 |
Keywords provided by Endo Pharmaceuticals:
'Dupuytren's contracture' 'xiapex' 'surgery' |
Additional relevant MeSH terms:
Contracture Dupuytren Contracture Joint Diseases Musculoskeletal Diseases Muscular Diseases Fibroma |
Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Connective Tissue Diseases |