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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01407068




Registration number
NCT01407068
Ethics application status
Date submitted
29/07/2011
Date registered
1/08/2011
Date last updated
5/10/2017

Titles & IDs
Public title
Administration of Two Injections for Multiple Dupuytren's Contractures
Scientific title
An Open-label Study to Assess the Safety and Efficacy of Concurrent Administration of Two Injections of AA4500 0.58 mg Into the Same Hand of Subjects With Multiple Dupuytren's Contractures
Secondary ID [1] 0 0
AUX-CC-864
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dupuytren's Contracture 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 - AA4500 collagenase clostridium histolyticum

Experimental: AA4500 - AA4500 collagenase clostridium histolyticum


Other interventions: AA4500 collagenase clostridium histolyticum
2 concurrent injections (0.58 mg) into 2 cords on the same hand

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

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Total Fixed Flexion - Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Timepoint [1] 0 0
30 days after last injection
Primary outcome [2] 0 0
Change in Total Range of Motion - The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.
Timepoint [2] 0 0
30 days after last injection
Secondary outcome [1] 0 0
Subject Satisfaction With Treatment - At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows:
Very Satisfied
Quite Satisfied
Neither Satisfied nor Dissatisfied
Quite Dissatisfied
Very Dissatisfied
Timepoint [1] 0 0
60 days after last injection
Secondary outcome [2] 0 0
Investigator Assessment of Improvement With Treatment - At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject's treated finger(s) compared with screening as follows:
Very Much Improved
Much improved
Minimally Improved
No Change
Minimally Worse
Much Worse
Very Much Worse
Timepoint [2] 0 0
60 days after last injection
Secondary outcome [3] 0 0
Clinical Success by Joint Type - Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.
Timepoint [3] 0 0
30 days after injection

Eligibility
Key inclusion criteria
1. Provide written informed consent

2. Be a man or woman = 18 years of age

3. Have a diagnosis of Dupuytren's disease and have at least 2 fixed-flexion contractures
on the same hand that are = 20º in PIP and/or MP joints in fingers, other than the
thumbs, which are caused by palpable cords suitable for treatment

4. Have a positive "table top test" defined as the inability to simultaneously place the
affected finger(s) and palm flat against a table top

5. Either be using an accepted method of birth control (ie, surgical sterilization; intra
uterine contraceptive device; oral contraceptive; diaphragm or condom in combination
with contraceptive cream, or jelly or foam) and have negative pregnancy testing before
administration of AA4500, if a female of childbearing potential, or be a
postmenopausal female (no menses for at least 1 year or hysterectomy)

6. Not have any clinically significant medical history or condition(s) that would, in the
opinion of the investigator, substantially increase the risk associated with the
subject's participation in the protocol or compromise the scientific objectives of the
study

7. 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. Received surgery (fasciectomy or surgical fasciotomy) and/or needle
aponeurotomy/fasciotomy on the selected joints to be treated within 90 days before the
first injection of AA4500

2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands

3. Has a known systemic allergy to collagenase or any other excipient of AA4500

4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX/XIAPEX)
within 30 days before injection of AA4500

5. Is currently receiving or plans to receive anticoagulant medication or has received
anticoagulant medication (except for = 150 mg aspirin daily and over-the-counter
nonsteroidal anti-inflammatory drugs [NSAIDs]) within 7 days before injection of
AA4500)

6. Has a known recent history of stroke, bleeding, or other medical condition, which in
the investigator's opinion would make the subject unsuitable for enrollment in the
study

7. Is known to be immunocompromised or human immunodeficiency virus (HIV) positive

8. Has a history of illicit drug abuse or alcoholism within the year before injection of
AA4500

9. Received an investigational drug within 30 days before injection of AA4500

10. Is a pregnant or lactating female

11. Has any clinically significant medical history or condition(s), including conditions
that affect the hands, that would, in the opinion of the investigator, substantially
increase the risk associated with the subject's participation in the protocol or
compromise the scientific objectives of the study

12. Has jewelry on the hand to be treated that cannot be removed

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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 3
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)
Recruitment hospital [1] 0 0
AusTrials - Auchenflower
Recruitment hospital [2] 0 0
AusTrials - Kippa Ring
Recruitment hospital [3] 0 0
Emeritus Research - Malvern
Recruitment postcode(s) [1] 0 0
QLD 4067 - Auchenflower
Recruitment postcode(s) [2] 0 0
QLD4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
QLD 4020 - Kippa Ring
Recruitment postcode(s) [4] 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
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma

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 concurrent
administration of two injections of AA4500 into the same hand of subjects with multiple
Dupuytren's contractures caused by palpable cords.
Trial website
https://clinicaltrials.gov/show/NCT01407068
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