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NCT00528424 · ClinicalTrials.gov registry record · Phase 3
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
A Phase 3 study of Advanced Dupuytren's Disease, sponsored by Endo Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 286
- Enrollment target
- 15
- Study locations
NCT00528424: Completed Phase 3 study of Advanced Dupuytren's Disease, sponsored by Endo Pharmaceuticals.
NCT00528424 is a Phase 3 study of Advanced Dupuytren's Disease that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 286 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00528424, a Phase 3 study of Advanced Dupuytren's Disease, has completed, sponsored by Endo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 286 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
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.
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 |
What the finished NCT00528424 record still lists
NCT00528424 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
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.
NCT00528424 lists 15 locations in 11 states (California, Massachusetts, New York).
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.
What interventions are being tested in trial NCT00528424?
The interventions under investigation include: AA4500 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00528424?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00528424's enrollment target sits among peer trials
286 1182nd of 2000 higher than 816 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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