Post Approval Commitment Study | NCT01444729

Studies
Post Approval Commitment Study

NCT01444729

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Status

Completed

Last Update Posted

Oct 26, 2017Actual

Enrollment

305Actual

Phase

Not provided

Conditions

Dupuytren's Contracture

Interventions

Xiapex
surgery

Countries

Norway
Spain

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

Oct 2017

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

Mar 2012

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Sep 8, 2011

First Submission Date that Met QC Criteria

Sep 30, 2011

First Posted Date

Oct 3, 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

Oct 25, 2017

Last Update Posted Date

Oct 26, 2017Actual

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

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.

Detailed Description

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

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

305Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
xiapex		Subject treated with Xiapex	Drug: Xiapex
Surgery		Fasciotomy or fasciectomy	Procedure: surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xiapex	Drug	Xiapex administration will follow SMPC	xiapex
surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical treatment success as assessed by goniometry		an expected average of 5 weeks
treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires		an expected average of 5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Treatment option as determined by treating physician in consultation with patient		at day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veronica Urdaneta	Endo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Auxilium Investigational Site		Bergen		5021	Norway
Auxilium Investigational Site

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

Intervention Browse Module

MeSH Terms

ID	Term
C570746	xiapex
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided