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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01498640




Registration number
NCT01498640
Ethics application status
Date submitted
17/12/2011
Date registered
23/12/2011
Date last updated
5/10/2017

Titles & IDs
Public title
Retreatment of Recurrent Dupuytren's Contractures
Scientific 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
Secondary ID [1] 0 0
AUX-CC-862
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
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Collagenase clostridium histolyticum

Experimental: XIAFLEX/XIAPEX MP Joint - Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord

Experimental: XIAFLEX/XIAPEX PIP Joint - Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord


Other interventions: Collagenase clostridium histolyticum
up to three 0.58 mg injections

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
30 days after last injection
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline and 30 days after last injection
Primary outcome [3] 0 0
Change in Range of Motion - Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
Timepoint [3] 0 0
Baseline and 30 days after last injection
Secondary outcome [1] 0 0
Physician Global Assessment of Improvement - Physician global assessment of change (improvement) in subject's Dupuytren's contracture
Timepoint [1] 0 0
30 days after last injection
Secondary outcome [2] 0 0
Subject Global Assessment of Satisfaction - Subject global assessment of overall treatment satisfaction
Timepoint [2] 0 0
30 days after last injection
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 365

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Peninsula Private Hospital - Kippa Ring
Recruitment hospital [2] 0 0
AusTrials Sherwood - Sherwood
Recruitment hospital [3] 0 0
Emeritus Research - Malvern East
Recruitment postcode(s) [1] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [2] 0 0
4075 - Sherwood
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
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
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Sweden
State/province [8] 0 0
SE
Country [9] 0 0
United Kingdom
State/province [9] 0 0
GB

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01498640
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Veronica Urdaneta, MD, MPPH
Address 0 0
Endo Pharmaceuticals
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
Other publications