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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00533273
Registration number
NCT00533273
Ethics application status
Date submitted
20/09/2007
Date registered
21/09/2007
Date last updated
2/12/2017
Titles & IDs
Public title
Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
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Scientific title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease Followed by an Open-Label Extension Phase
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Secondary ID [1]
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AUX CC 859
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Universal Trial Number (UTN)
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Trial acronym
CORD-II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Dupuytren's Disease
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - collagenase clostridium histolyticum
Experimental: AA4500 0.58 mg -
Placebo comparator: Placebo -
Treatment: Other: collagenase clostridium histolyticum
Subjects could have received up to three injections of AA4500 0.58 mg/placebo into the cord of the affected hand in the double-blind phase. In the open-label extension phase, subjects could have received up to five additional injections of AA4500, with each injection separated by at least 30 days. Individual joints could have received up to a maximum of three AA4500 injections.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Reduction in Primary Joint Contracture to 5° or Less
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Assessment method [1]
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Successfully treated or clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
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Timepoint [1]
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Within 30 days after last injection
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Secondary outcome [1]
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Clinical Improvement in Primary Joint After the Last Injection
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Assessment method [1]
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Clinical improvement in primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection
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Timepoint [1]
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Baseline, Within 30 days after last injection
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Secondary outcome [2]
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Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection
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Assessment method [2]
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Percent change in degree of contracture of primary joint measured as 100 \* (baseline contracture - last available post-injection contracture)/baseline contracture
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Timepoint [2]
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Baseline, Day 30 after last injection
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Secondary outcome [3]
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Change From Baseline Range of Motion in Primary Joint After the Last Injection
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Assessment method [3]
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Change in degree of range of motion in primary joint measured as last available post-injection range of motion - baseline range of motion
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Timepoint [3]
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Baseline, Day 30 after last injection
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Secondary outcome [4]
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Time to Reach Clinical Success in Primary Joint
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Assessment method [4]
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Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
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Timepoint [4]
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Within 30 days after last injection
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Secondary outcome [5]
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Clinical Success in Primary Joint After the First Injection
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Assessment method [5]
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Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
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Timepoint [5]
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Within 30 days after first injection
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Secondary outcome [6]
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Clinical Improvement in Primary Joint After the First Injection
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Assessment method [6]
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Clinical improvement in primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection
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Timepoint [6]
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Baseline, Within 30 days after first injection
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Secondary outcome [7]
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Percent Reduction From Baseline Contracture of Primary Joint After the First Injection
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Assessment method [7]
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Percent change in degree of contracture of primary joint measured as 100 \* (baseline contracture - last available post-injection contracture prior to next injection)/baseline contracture
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Timepoint [7]
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Baseline, Day 30 after first injection
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Secondary outcome [8]
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Change From Baseline Range of Motion in Primary Joint After the First Injection
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Assessment method [8]
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Change in degree of range of motion in primary joint measured as last available post-injection range of motion prior to the next injection - baseline range of motion
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Timepoint [8]
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Baseline, Day 30 after first injection
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Secondary outcome [9]
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Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection
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Assessment method [9]
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Successfully treated or clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
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Timepoint [9]
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Within 30 days after last injection
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Secondary outcome [10]
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Clinical Improvement in Non-Primary Joint After the Last Injection
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Assessment method [10]
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Clinical improvement in non-primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection
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Timepoint [10]
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Baseline, Within 30 days after last injection
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Secondary outcome [11]
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Percent Reduction From Baseline Contracture of Non-Primary Joint After the Last Injection
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Assessment method [11]
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Percent change in degree of contracture of non-primary joint measured as 100 \* (baseline contracture - last available post-injection contracture)/baseline contracture
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Timepoint [11]
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Baseline, Day 30 after last injection
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Secondary outcome [12]
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Change From Baseline Range of Motion in Non-Primary Joint After the Last Injection
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Assessment method [12]
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Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion - baseline range of motion
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Timepoint [12]
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Baseline, Day 30 after last injection
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Secondary outcome [13]
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Time to Reach Clinical Success in Non-Primary Joint
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Assessment method [13]
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Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
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Timepoint [13]
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Within 30 days after last injection
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Secondary outcome [14]
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Clinical Success in Non-Primary Joint After the First Injection
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Assessment method [14]
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Clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
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Timepoint [14]
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Within 30 days after first injection
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Secondary outcome [15]
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Clinical Improvement in Non-Primary Joint After the First Injection
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Assessment method [15]
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Clinical improvement in non-primary joint defined as =50% reduction from baseline in the degree of contracture within 30 days after injection
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Timepoint [15]
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Baseline, Within 30 days after first injection
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Secondary outcome [16]
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Percent Reduction From Baseline Contracture of Non-Primary Joint After the First Injection
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Assessment method [16]
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Percent change in degree of contracture of non-primary joint measured as 100 \* (baseline contracture - last available post-injection contracture prior to next injection)/baseline contracture
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Timepoint [16]
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Baseline, Day 30 after first injection
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Secondary outcome [17]
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Change From Baseline Range of Motion in Non-Primary Joint After the First Injection
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Assessment method [17]
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Change in degree of range of motion in non-primary joint measured as last available post-injection range of motion prior to the next injection - baseline range of motion
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Timepoint [17]
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Baseline, Day 30 after first injection
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Eligibility
Key inclusion criteria
* Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord.
* Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
* Were naive to AA4500 treatment
* Were judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
* Had received a treatment for advanced Dupuytren's disease, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
* Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2008
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Sample size
Target
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Accrual to date
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Final
66
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Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC,WA
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Recruitment hospital [1]
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Rivercity Research - Auchenflower
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Recruitment hospital [2]
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Brisbane Hand & Upper Limb Clinic - Brisbane
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Recruitment hospital [3]
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Caboolture Clinical Research Centre - Caboolture
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Recruitment hospital [4]
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Peninsula Clinical Research Centre - Kippa Ring
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Recruitment hospital [5]
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Menzies Reserarch Institute - Hobart
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Recruitment hospital [6]
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Emeritus Research - Malvern
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Recruitment hospital [7]
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Royal Perth Hospital - Shenton Park
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Recruitment postcode(s) [1]
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4067 - Auchenflower
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Recruitment postcode(s) [2]
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4000 - Brisbane
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Recruitment postcode(s) [3]
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4510 - Caboolture
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Recruitment postcode(s) [4]
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4019 - Kippa Ring
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Recruitment postcode(s) [5]
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7000 - Hobart
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Recruitment postcode(s) [6]
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3144 - Malvern
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Recruitment postcode(s) [7]
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6007 - Shenton Park
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Endo Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This 12-month study had two phases: a 90-day double-blind, randomized, placebo-controlled phase and a nine-month open-label extension phase. Before treatment, eligible subjects were stratified by the primary joint type (30 metacarpophalangeal \[MP\] joints and 30 proximal interphalangeal \[PIP\] joints) and by severity of the primary joint contracture (ie, up to 50° or \>50° for MP joints and up to 40° or \>40° for PIP joints) and then randomized in a 2:1 ratio to either AA4500 0.58 mg or placebo. Upon completion of the double-blind phase (ie, 90-day evaluation after the first injection), all subjects were eligible to enter the open-label extension phase of the study in which they were followed for an additional nine months. Subjects who required further treatment because they either did not achieve reduction in contracture to 5° or less, the cord affecting the primary joint received placebo, another cord received less than three injections of AA4500, or they had untreated cords that were affecting other joints had the option to receive up to five additional injections of AA4500 0.58 mg in the open-label extension phase, with individual cords receiving up to three injections of AA4500. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 \[NCT00528606\] and AUX-CC-859 \[NCT00533273\]) and 7 non-pivotal studies were evaluated.
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Trial website
https://clinicaltrials.gov/study/NCT00533273
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Veronica Urdaneta, MD
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Address
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Endo Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00533273
Download to PDF