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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