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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
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Dupuytren's Contracture Drug: Xiapex Procedure: surgery

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

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. clinical treatment success as assessed by goniometry [ Time Frame: an expected average of 5 weeks ]
  2. treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires [ Time Frame: an expected average of 5 weeks ]

Secondary Outcome Measures :
  1. Treatment option as determined by treating physician in consultation with patient [ Time Frame: at day 1 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
Study Population
- Adults with a palpable cord eligible for the treatment of Dupuytren's contracture
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Veronica Urdaneta Endo
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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