Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Public ClinicalTrials.gov record NCT00528840. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease 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 evaluation and injection were enrolled. 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.
Study identification
- NCT ID
- NCT00528840
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 201 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2007
- Primary completion
- Sep 30, 2008
- Completion
- Sep 30, 2008
- Last update posted
- Dec 1, 2017
2007 – 2008
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85050 | — |
| Tucson Orthopedic Institute, P.C. | Tucson | Arizona | 85172 | — |
| Providence Clinical Research | Burbank | California | 91505 | — |
| Southern Illinois Hand Center, S.C. | Effingham | Illinois | 62401 | — |
| Rockford Orthopedic Associates, Ltd. | Rockford | Illinois | 61107 | — |
| The Indiana Hand Center | Indianapolis | Indiana | 46260 | — |
| Pri Via | Wichita | Kansas | 67214 | — |
| St. Alexius Medical Center | Bismarck | North Dakota | 58501 | — |
| David R. Mandel, Inc. | Mayfield | Ohio | 44143 | — |
| St. Vincent Medical Center | Portland | Oregon | 97225 | — |
| Hamot Center for Clinical Research | Erie | Pennsylvania | 16550 | — |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | — |
| The Rheumatic Disease Clinic of Houston | Houston | Texas | 77004 | — |
| Accurate Clincal Research | Houston | Texas | 77034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00528840, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00528840 live on ClinicalTrials.gov.