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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00528840 |
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Date of registration:
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11/09/2007 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
JOINT-I |
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Scientific title:
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A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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201 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00528840 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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John Rodzvilla, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Auxilium Pharmaceuticals, Inc |
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Key inclusion & exclusion criteria
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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 one or two injections of AA4500 for
the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851,
AUX-CC-853, or AUX-CC-855.
- Were judged to be in good health.
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Dupuytren's Disease
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Intervention(s)
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Biological: collagenase clostridium histolyticum
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Primary Outcome(s)
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Reduction in Contracture to 5° or Less
[Time Frame: Within 30 days after the last injection]
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Secondary Outcome(s)
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Change From Baseline Range of Motion After the First Injection
[Time Frame: 30 days after first treatment]
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Change From Baseline Range of Motion After the Last Injection
[Time Frame: 30 days after last treatment]
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Clinical Improvement After the First Injection
[Time Frame: 30 days after first treatment]
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Clinical Improvement After the Last Injection
[Time Frame: 30 days after last treatment]
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Clinical Success After the First Injection
[Time Frame: 30 days after first treatment]
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Percent Reduction From Baseline Contracture After the First Injection
[Time Frame: 30 days after first treatment]
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Percent Reduction From Baseline Contracture After the Last Injection
[Time Frame: 30 days after last treatment]
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Time to First Achieve and Maintain Clinical Success After the Last Injection
[Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation]
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Secondary ID(s)
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AUX-CC-856
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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