NCT01444729

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

September 8, 2011

Last Update Submit

October 25, 2017

Conditions

Dupuytren's Contracture

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • clinical treatment success as assessed by goniometry

    an expected average of 5 weeks

  • treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires

    an expected average of 5 weeks

Secondary Outcomes (1)

  • Treatment option as determined by treating physician in consultation with patient

    at day 1

Study Arms (2)

xiapex

Subject treated with Xiapex

Drug: Xiapex

Surgery

Fasciotomy or fasciectomy

Procedure: surgery

Interventions

XiapexDRUG

Xiapex administration will follow SMPC

xiapex
surgeryPROCEDURE

Non-pharmacological treatment

Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Auxilium Investigational Site

Bergen, 5021, Norway

Location

Auxilium Investigational Site

Drammen, 3004, Norway

Location

Auxilium Investigational Site

Málaga, Andalusia, 29010, Spain

Location

Auxilium Investigational Site

Alcorcón, Madrid, 28922, Spain

Location

Auxilium Investigational Site

Majadahonda, Madrid, 28222, Spain

Location

Auxilium Investigational Site

Pamplona, Navarre, 31008, Spain

Location

Auxilium Investigational Site

Valladolid, 46011, Spain

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

xiapexSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Veronica Urdaneta

    Endo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

October 3, 2011

Study Start

March 1, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

ES(5)NO(2)