Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study of Advanced Dupuytren's Disease that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 286 participants. The trial reports 15 study locations across 11 states.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. 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.
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 reports 15 study locations spanning 11 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.