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AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
NCT00528424 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL AA4500
Study Locations (15)
California
- 100 UCLA Medical Plaza, Suite 305 — Los Angeles
- Hand Surgery Clinic — Palo Alto
Massachusetts
- Brigham and Women's Hospital, Department of Orthopedic Surgery — Boston
- Newton-Wellesley Hospital — Newton
New York
- Hospital for Special Surgery — New York
- SUNY Stony Brook - Department of Orthopedics — Stony Brook
Pennsylvania
- Hand Microsurgery & Reconstructive Orthopaedics — Erie
- University Orthopedics Center — State College
Colorado
- Hand Surgery Associates, PC — Denver
Georgia
- The Hand and Upper Extremity Center of Georgia, P.C. — Atlanta
Illinois
- Rockford Orthopedic Associates, Ltd. — Rockford
Indiana
- The Indiana Hand Center — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00528424
The ClinicalTrials.gov registry entry for NCT00528424 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Dupuytren's Disease appearing as the primary indexed condition, and to 1 intervention — of which AA4500 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00528424 reports 15 study locations spanning 11 distinct geographic areas — top geographies include California, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00528424 about?
NCT00528424 is a clinical study titled "AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease". 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, eithe...
What is the current status of trial NCT00528424?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 286 participants. The study started on 2007-12. Estimated completion is 2008-11.
What conditions does trial NCT00528424 study?
This clinical trial studies the following conditions: Advanced Dupuytren's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00528424?
The interventions under investigation include: AA4500 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00528424?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00528424 being conducted?
This trial has 15 study locations across California, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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