Phase 3
N=308
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
Dupuytren's Contracture
Bottom Line
View on ClinicalTrials.gov: NCT00528606 ↗Enrolled (actual)
308
Serious AEs
2.9%
Results posted
Oct 2010
Primary outcome: Primary: Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection — 64; 6.8 Percentage of Joints — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- collagenase clostridium histolyticum (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection |
64; 6.8 | <0.001 sig |
| SECONDARY Clinical Improvement After the Last Injection |
84.7; 11.7 | — |
| SECONDARY Percent Reduction From Baseline Contracture After the Last Injection |
79.3; 8.6 | — |
| SECONDARY Change From Baseline Range of Motion After the Last Injection |
36.70; 4.0 | — |
| SECONDARY Time to First Achieve Success After the Last Injection |
12.8; 0.0; 12.3; 0.0; 14.3; 1.0 | — |
| SECONDARY Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection |
38.9; 1.0 | — |
| SECONDARY Clinical Improvement After the First Injection |
67.5; 2.9 | — |
| SECONDARY Percent Reduction From Baseline Contracture After the First Injection |
64.8; 4.7 | — |
| SECONDARY Change From Baseline Range of Motion After the First Injection |
28.30; 1.50 | — |
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.
Eligibility Criteria
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.
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.
Data sourced from ClinicalTrials.gov (NCT00528606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.