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
  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

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 ] [ Designated as safety issue: No ]
  • treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires [ Time Frame: an expected average of 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment option as determined by treating physician in consultation with patient [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

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)
Genders Eligible for Study:   Both
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
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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 August 23, 2016