Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00954746




Registration number
NCT00954746
Ethics application status
Date submitted
6/08/2009
Date registered
7/08/2009
Date last updated
16/06/2015

Titles & IDs
Public title
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
Scientific title
CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study
Secondary ID [1] 0 0
AUX-CC-860
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dupuytren's Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Follow-up - Subjects Previously Treated with AA4500
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Contracture Measurements
Timepoint [1] 0 0
yearly
Secondary outcome [1] 0 0
Immunogenicity, concomitant medications, medical history, and adverse events
Timepoint [1] 0 0
yearly

Eligibility
Key inclusion criteria
To be eligible for this study a subject had to:

* Have received at least one injection of AA4500 in one of the Auxilium sponsored studies (AUX-CC-854, AUX-CC-856, Studies AUX-CC-857/AUX-CC-858, or AUX-CC-859) and have at least one fixed-flexion contracture measurement after treatment with AA4500
* Be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator
* Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
645
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Rivercity Hospital - Auchenflower
Recruitment hospital [3] 0 0
Caboolture Clinical Research Centre - Caboolture
Recruitment hospital [4] 0 0
Peninsula Clinical Research - Kippa Ring
Recruitment hospital [5] 0 0
Menzies Research Institute - Hobart
Recruitment hospital [6] 0 0
Emeritus Research - Malvern
Recruitment postcode(s) [1] 0 0
NSW 2065 - St Leonards
Recruitment postcode(s) [2] 0 0
QLD4067 - Auchenflower
Recruitment postcode(s) [3] 0 0
QLD4510 - Caboolture
Recruitment postcode(s) [4] 0 0
QLD 4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
TAS7000 - Hobart
Recruitment postcode(s) [6] 0 0
VIC 3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Dakota
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
Denmark
State/province [17] 0 0
Copenhagen
Country [18] 0 0
Denmark
State/province [18] 0 0
Aalborg
Country [19] 0 0
Finland
State/province [19] 0 0
Helsinki
Country [20] 0 0
Finland
State/province [20] 0 0
Tampere
Country [21] 0 0
Sweden
State/province [21] 0 0
Malmo
Country [22] 0 0
Sweden
State/province [22] 0 0
Uppsala
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Derbyshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Newcastle Upon Tyne
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endo Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.
Trial website
https://clinicaltrials.gov/study/NCT00954746
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Veronica Urdaneta, MD
Address 0 0
Endo Health Solutions
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00954746