Dupuytren's Contracture Clinical Trial
Official title:
A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture
| Verified date | October 2017 |
| Source | Endo Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 305 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adults with a palpable cord eligible for the treatment of Dupuytren's contracture Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Auxilium Investigational Site | Bergen | |
| Norway | Auxilium Investigational Site | Drammen | |
| Spain | Auxilium Investigational Site | Alcorcon | Madrid |
| Spain | Auxilium Investigational Site | Majadahonda | Madrid |
| Spain | Auxilium Investigational Site | Malaga | Andalucia |
| Spain | Auxilium Investigational Site | Pamplona | Navarra |
| Spain | Auxilium Investigational Site | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| Endo Pharmaceuticals |
Norway, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical treatment success as assessed by goniometry | an expected average of 5 weeks | ||
| Primary | treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires | an expected average of 5 weeks | ||
| Secondary | Treatment option as determined by treating physician in consultation with patient | at day 1 |
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