Post Approval Commitment Study

Endo Pharmaceuticals

Status: Completed

Conditions: Dupuytren's Contracture

Treatments: Procedure: surgery; Drug: Xiapex

Study type: Observational

Funder types: Industry

Identifiers

NCT01444729

B1531005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

none

Trial design

305 participants in 2 patient groups

xiapex

Description:

Subject treated with Xiapex

Treatment:

Drug: Xiapex

Surgery

Description:

Fasciotomy or fasciectomy

Treatment:

Procedure: surgery