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Post Approval Commitment Study

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01444729
First received: September 8, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

Pfizer has committed 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.


Condition Intervention Phase
DUPUYTREN'S CONTRACTURE
 Drug: Xiapex
Procedure: surgery
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • clinical treatment success as assessed by goniometry [ Time Frame: an expected average of 5 weeks ] [ Designated as safety issue: No ]
  • treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires [ Time Frame: an expected average of 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment option as determined by treating physician in consultation with patient [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: March 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
xiapex
Subject treated with Xiapex
 Drug: Xiapex
Xiapex administration will follow SMPC
Surgery
Fasciotomy or fasciectomy
 Procedure: surgery
Non phamacologic treatment

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444729

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Norway
Pfizer Investigational Site Recruiting
Bergen, Norway, 5021
Pfizer Investigational Site Recruiting
Drammen, Norway, 3004
Spain
Pfizer Investigational Site Recruiting
Malaga, Andalucia, Spain, 29010
Pfizer Investigational Site Recruiting
Alcorcon, Madrid, Spain, 28922
Pfizer Investigational Site Recruiting
Majadahonda, Madrid, Spain, 28222
Pfizer Investigational Site Recruiting
Pamplona, Navarra, Spain, 31008
Pfizer Investigational Site Recruiting
Valladolid, Spain, 46011
United Kingdom
Pfizer Investigational Site Not yet recruiting
Bournemouth, United Kingdom, BH77DW
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01444729     History of Changes
Other Study ID Numbers: B1531005
Study First Received: September 8, 2011
Last Updated: May 14, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Pfizer:
'Dupyuitren's contrature' 'xiapex' 'surgery'

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
 Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 22, 2013