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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00528606
Registration number
NCT00528606
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 Dupuytren's Contracture
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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 Dupuytren's Contracture
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Secondary ID [1]
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AUX-CC-857
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Universal Trial Number (UTN)
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Trial acronym
CORD-I
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dupuytren's Contracture
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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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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - collagenase clostridium histolyticum
Other interventions - Placebo
Experimental: AA4500 0.58 mg -
Placebo Comparator: Placebo -
Other interventions: collagenase clostridium histolyticum
Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
Other interventions: Placebo
Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
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Intervention code [1]
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Other interventions
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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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Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection
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Assessment method [1]
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The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was 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 the 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 is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection.
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Timepoint [1]
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Baseline; within 30 days after the 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 measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.
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Timepoint [2]
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Baseline; within 30 days after the 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 motion measured as last available post-injection range of motion - baseline range of motion.
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Timepoint [3]
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Baselin; within 30 days after the last injection
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Secondary outcome [4]
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Time to First Achieve Success After the Last Injection
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Assessment method [4]
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Timepoint [4]
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Last evaluation visit on which clinical success is achieved through the Day 30 evaluation
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Secondary outcome [5]
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Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection
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Assessment method [5]
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Clinical Success is defined as reduction in contracture to within 0-5 degrees 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 is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.
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Timepoint [6]
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Baseline; within 30 days after the 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 measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.
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Timepoint [7]
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Baseline, within 30 days after the 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 motion measured as last available post-injection range of motion - baseline range of motion.
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Timepoint [8]
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Baseline; within 30 days after the first injection
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Eligibility
Key inclusion criteria
- Subjects with a diagnosis of Dupuytren's contracture, 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 that had
never been treated with AA4500.
- Had a positive "table top test," defined as the inability to simultaneously place the
affected finger(s) and palm flat against a table top.
- Judged to be in good health.
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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 Dupuytren's contracture, 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 administering the treatment/s
The people assessing the outcomes
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
1/04/2008
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Sample size
Target
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Accrual to date
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Final
308
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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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Country [2]
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United States of America
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State/province [2]
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Colorado
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United States of America
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State/province [3]
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Georgia
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United States of America
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State/province [4]
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Illinois
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Country [5]
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State/province [5]
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Indiana
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Country [6]
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State/province [6]
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Massachusetts
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Country [7]
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State/province [7]
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Minnesota
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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Oklahoma
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Country [10]
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United States of America
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State/province [10]
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Pennsylvania
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Country [11]
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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
This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the
United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal
(MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at
least one finger, other than the thumb, that was at least 20° as measured by finger
goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or
placebo.
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/ct2/show/NCT00528606
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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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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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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00528606
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