Registry of Dupuytren's Contracture Treatment Outcomes | NCT01567397

Studies
Registry of Dupuytren's Contracture Treatment Outcomes

NCT01567397

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Dec 22, 2016Estimated

Enrollment

87Actual

Phase

Not provided

Conditions

Dupuytren's Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Mar 28, 2012

First Submission Date that Met QC Criteria

Mar 29, 2012

First Posted Date

Mar 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2016

Last Update Posted Date

Dec 22, 2016Estimated

Name	Class
GWT-TUD GmbH	OTHER
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.Thus, the present study aims to collect data on the

Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice
Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy)
Effectiveness (with focus on functionality)
Tolerability
Patient-related outcomes: patient satisfaction, health-related quality of life
Physician satisfaction with therapy
Resource utilization (hospital stays, drug consumption, concomitant medication etc.)
Long-term outcomes

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

palpable cord due to Dupuytren's Disease (pretreated or untreated)
satisfactory knowledge of German to be able to fill out questionnaires
written informed consent

Exclusion Criteria:

contraindication to Microbial Collagenase (according to Prescription Information)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Dupuytren's Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Pittrow, MD, PhD	Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany	Study Director
Wilhelm Kirch, MD, PhD	Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, Germany	Principal Investigator
Max Härle, MD	Orthopädische Klinik, Markgröningen, Germany	Study Director
Jörg Witthaut, MD	Schön Klinik Vogtareuth	Study Director
Riccardo Giunta, MD	Hand Surgery, Ludwig-Maximilian-University Munich, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. Max Haerle		Markgröningen			Germany
Prof. Dr. Riccardo Giunta

References Module

Citations

Not provided

ID	Term
D005350	Fibroma
D018218	Neoplasms, Fibrous Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue