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Post Approval Commitment Study

NCT ID: NCT01444729

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

305 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-11-30

Brief Summary

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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

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

Conditions

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Dupuytren's Contracture

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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xiapex

Subject treated with Xiapex

Xiapex

Intervention Type DRUG

Xiapex administration will follow SMPC

Surgery

Fasciotomy or fasciectomy

surgery

Intervention Type PROCEDURE

Non-pharmacological treatment

Interventions

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Xiapex

Xiapex administration will follow SMPC

Intervention Type DRUG

surgery

Non-pharmacological treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronica Urdaneta

Role: STUDY_DIRECTOR

Endo

Locations

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Auxilium Investigational Site

Bergen, , Norway

Site Status

Auxilium Investigational Site

Drammen, , Norway

Site Status

Auxilium Investigational Site

Málaga, Andalusia, Spain

Site Status

Auxilium Investigational Site

Alcorcón, Madrid, Spain

Site Status

Auxilium Investigational Site

Majadahonda, Madrid, Spain

Site Status

Auxilium Investigational Site

Pamplona, Navarre, Spain

Site Status

Auxilium Investigational Site

Valladolid, , Spain

Site Status

Countries

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United Kingdom Norway Spain

Other Identifiers

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B1531005

Identifier Type: -

Identifier Source: org_study_id