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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01444729
Other study ID # B1531005
Secondary ID
Status Completed
Phase N/A
First received September 8, 2011
Last updated October 25, 2017
Start date March 2012
Est. completion date November 2015

Study information

Verified date October 2017
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

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:

Study Design


Intervention

Drug:
Xiapex
Xiapex administration will follow SMPC
Procedure:
surgery
Non-pharmacological treatment

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Countries where clinical trial is conducted

Norway,  Spain, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01674634 - Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures Phase 3
Completed NCT01715467 - CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment N/A
Completed NCT01407068 - Administration of Two Injections for Multiple Dupuytren's Contractures Phase 3
Completed NCT00528931 - A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture Phase 1
Completed NCT00565019 - Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture Phase 3
Completed NCT01588353 - Collagenase Option for Reduction of Dupuytren's Contracture in Japan Phase 3
Completed NCT00468949 - Health-Related Quality of Life in Patients With Dupuytren's Disease Phase 1
Terminated NCT05877066 - Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Completed NCT01229436 - Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) Phase 3
Completed NCT01265420 - Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb Phase 4
Completed NCT00528606 - AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture Phase 3
Completed NCT00931567 - Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing Phase 2/Phase 3
Completed NCT00004409 - Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease Phase 2
Completed NCT00014742 - Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease Phase 3