Post Approval Commitment Study

October 25, 2017 updated by: Endo Pharmaceuticals

A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Auxilium Investigational Site
      • Drammen, Norway, 3004
        • Auxilium Investigational Site
  • Spain
      • Valladolid, Spain, 46011
        • Auxilium Investigational Site
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Auxilium Investigational Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Auxilium Investigational Site
      • Majadahonda, Madrid, Spain, 28222
        • Auxilium Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Auxilium Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical treatment success as assessed by goniometry
Time Frame: an expected average of 5 weeks
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
an expected average of 5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Investigators

  • Study Director: Veronica Urdaneta, Endo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 3, 2011

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1531005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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