Post Approval Commitment Study
This study has been completed.
Sponsor:
Endo Pharmaceuticals
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
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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:
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
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 September 28, 2016