Post Approval Commitment Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Endo Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01444729

First received: September 8, 2011

Last updated: June 17, 2016

Last verified: June 2016

History of Changes

Purpose

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	Intervention	Phase
Dupuytren's Contracture	Drug: Xiapex Procedure: surgery	Phase 4


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Dupuytren contracture

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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


Estimated Enrollment:	250
Study Start Date:	March 2012
Study Completion Date:	November 2015
Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
xiapex Subject treated with Xiapex	Drug: Xiapex Xiapex administration will follow SMPC
Surgery Fasciotomy or fasciectomy	Procedure: surgery Non-pharmacological treatment

Detailed Description:

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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01444729 History of Changes
Other Study ID Numbers:	B1531005
Study First Received:	September 8, 2011
Last Updated:	June 17, 2016

Keywords provided by Endo Pharmaceuticals:


'Dupuytren's contracture' 'xiapex' 'surgery'

Additional relevant MeSH terms:


Contracture Dupuytren Contracture Joint Diseases	Musculoskeletal Diseases Muscular Diseases Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 26, 2017

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