Validation of Two New Questionnaires for Dupuytren's Disease | NCT01446432

Studies
Validation of Two New Questionnaires for Dupuytren's Disease

NCT01446432

Sponsor

Robert Hotchkiss

Status

Unknown status

Last Update Posted

Apr 3, 2015Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Dupuytren's Disease

Interventions

Not provided

Countries

United States

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Oct 3, 2011

First Submission Date that Met QC Criteria

Oct 4, 2011

First Posted Date

Oct 5, 2011Estimated

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

Apr 1, 2015

Last Update Posted Date

Apr 3, 2015Estimated

Name	Class
Auxilium Pharmaceuticals, Inc.	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

A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are standard and validated questionnaire instruments used to measure health related quality of life and function, they do not address patient specific issues. The investigators will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's Disease.

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

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QuickDASH (Disability of the Arm, Shoulder, and Hand)		30 day follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has a diagnosis of Dupuytren's Disease in at least one finger
Patients will be 35 years of age or older
Patients will be able to read, speak, and understand English
Patients will be able to provide voluntary written consent to participate

Exclusion Criteria:

Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
Patient has a known allergy to collagenase or any other excipient of XIAFLEX.
Patient has received any collagenase treatments before the first dose of XIAFLEX.
Any history of or current medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving treatment with XIAFLEX for Dupuytren's Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert N Hotchkiss, MD	Hosptial for Special Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital For Special Surgery		New York	New York	10021	United States

Condition Browse Module

MeSH Terms

ID	Term
D004387	Dupuytren Contracture

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided