Skip to main content
OpenTrials
Completed

NCT Number: NCT01444729

Post Approval Commitment Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dupuytren's Contracture Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Auxilium Investigational Site, Bergen, Norway

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

Xiapex

Drug

Xiapex administration will follow SMPC

Surgery

Procedure

Non-pharmacological treatment

Primary outcomes

  1. clinical treatment success as assessed by goniometry

    Time frame: an expected average of 5 weeks

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

    Time frame: an expected average of 5 weeks

Secondary outcomes

  1. Treatment option as determined by treating physician in consultation with patient

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2011
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.