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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00528424
Registration number
NCT00528424
Ethics application status
Date submitted
11/09/2007
Date registered
12/09/2007
Date last updated
2/12/2017
Titles & IDs
Public title
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
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Scientific title
A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
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Secondary ID [1]
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AUX-CC-858
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Universal Trial Number (UTN)
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Trial acronym
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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 - AA4500
Experimental: AA4500 0.58 mg -
Treatment: Other: AA4500
Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may 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 Contracture to 5° or Less
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Assessment method [1]
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Successfully treated or clinical success in non-primary joints 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 After the Last Injection
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Assessment method [1]
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Clinical improvement in non-primary joints 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 After the Last Injection
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Assessment method [2]
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Percent change in degree of contracture in non-primary joints 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 After the Last Injection
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Assessment method [3]
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Change in degree of range of motion in non-primary joints 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
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Assessment method [4]
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Clinical success in non-primary joints 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 After the First Injection
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Assessment method [5]
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Clinical success in non-primary joints 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 After the First Injection
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Assessment method [6]
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Clinical improvement in non-primary joints 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 After the First Injection
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Assessment method [7]
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Percent change in degree of contracture in non-primary joints measured as 100 \* (baseline contracture - last available post-injection contracture)/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 After the First Injection
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Assessment method [8]
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Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
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Timepoint [8]
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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 naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
* Were judged to be in good health.
* Must have participated in protocol AUX-CC-857 (NCT00528606).
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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 treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
* 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
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/12/2007
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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
1/11/2008
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Sample size
Target
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Accrual to date
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Final
286
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Georgia
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Illinois
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Indiana
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United States of America
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Massachusetts
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Minnesota
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New York
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Oklahoma
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Pennsylvania
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United States of America
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State/province [11]
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Rhode Island
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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
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9. 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/NCT00528424
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Veronica Urdaneta, MD
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Address
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Endo Pharmaceuticals
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Fax
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Email
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Contact person for public queries
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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/NCT00528424
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