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Retreatment of Recurrent Dupuytren's Contractures

Primary Purpose

Dupuytren's Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Collagenase clostridium histolyticum
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren's Disease focused on measuring XIAFLEX, XIAPEX, Dupuytren's disease, contracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provide written informed consent
  2. Be currently participating in the AUX-CC-860 follow-up study

  3. Have at least one joint with all of the following:

    • The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
    • The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
    • A palpable cord is present in the joint to be treated
  4. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria:

  1. Is a pregnant or lactating female or female intending to become pregnant during the study
  2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
  3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500

Sites / Locations

  • HOPE Research Institute
  • Rockford Orthopedic Associates
  • The Indiana Hand to Shoulder Center
  • Marquette General Health System
  • East River Professional Building
  • Health Reserarch Institute
  • Hand Microsurgery and Reconstructive Orthopaedics
  • Peninsula Private Hospital
  • AusTrials Sherwood
  • Emeritus Research
  • Uppsala Akademiska University Hospital
  • Pulvertaft Hand Center
  • Newcastle Upon Tyne Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

XIAFLEX/XIAPEX MP Joint

XIAFLEX/XIAPEX PIP Joint

Arm Description

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord

Outcomes

Primary Outcome Measures

Clinical Success
Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
Percent Change From Baseline in Degree of Contracture
Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Change in Range of Motion
Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees

Secondary Outcome Measures

Physician Global Assessment of Improvement
Physician global assessment of change (improvement) in subject's Dupuytren's contracture
Subject Global Assessment of Satisfaction
Subject global assessment of overall treatment satisfaction
Recurrence of Contracture
Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.

Full Information

First Posted
December 17, 2011
Last Updated
September 7, 2017
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01498640
Brief Title
Retreatment of Recurrent Dupuytren's Contractures
Official Title
Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.
Detailed Description
Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study. Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Disease
Keywords
XIAFLEX, XIAPEX, Dupuytren's disease, contracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XIAFLEX/XIAPEX MP Joint
Arm Type
Experimental
Arm Description
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
Arm Title
XIAFLEX/XIAPEX PIP Joint
Arm Type
Experimental
Arm Description
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
Intervention Type
Biological
Intervention Name(s)
Collagenase clostridium histolyticum
Other Intervention Name(s)
XIAFLEX, XIAPEX, AA4500
Intervention Description
up to three 0.58 mg injections
Primary Outcome Measure Information:
Title
Clinical Success
Description
Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
Time Frame
30 days after last injection
Title
Percent Change From Baseline in Degree of Contracture
Description
Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Time Frame
Baseline and 30 days after last injection
Title
Change in Range of Motion
Description
Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
Time Frame
Baseline and 30 days after last injection
Secondary Outcome Measure Information:
Title
Physician Global Assessment of Improvement
Description
Physician global assessment of change (improvement) in subject's Dupuytren's contracture
Time Frame
30 days after last injection
Title
Subject Global Assessment of Satisfaction
Description
Subject global assessment of overall treatment satisfaction
Time Frame
30 days after last injection
Title
Recurrence of Contracture
Description
Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.
Time Frame
Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide written informed consent Be currently participating in the AUX-CC-860 follow-up study Have at least one joint with all of the following: The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study A palpable cord is present in the joint to be treated Be able to comply with the study visit schedule as specified in the protocol Exclusion Criteria: Is a pregnant or lactating female or female intending to become pregnant during the study Has hypersensitivity to AA4500 or any of the AA4500 excipients Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Urdaneta, MD, MPPH
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Rockford Orthopedic Associates
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
The Indiana Hand to Shoulder Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Marquette General Health System
City
Marquette
State/Province
Michigan
ZIP/Postal Code
49855
Country
United States
Facility Name
East River Professional Building
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Health Reserarch Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Hand Microsurgery and Reconstructive Orthopaedics
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Peninsula Private Hospital
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
AusTrials Sherwood
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
Country
Australia
Facility Name
Emeritus Research
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Uppsala Akademiska University Hospital
City
Uppsala
State/Province
SE
ZIP/Postal Code
SE-751
Country
Sweden
Facility Name
Pulvertaft Hand Center
City
Derby
State/Province
GB
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals
City
Newcastle
State/Province
GB
ZIP/Postal Code
NE1 4LP
Country
United Kingdom

12. IPD Sharing Statement

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Retreatment of Recurrent Dupuytren's Contractures

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