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NCT00260429 · ClinicalTrials.gov registry record · Phase 3
Collagenase in the Treatment of Dupuytrens Disease
A Phase 3 study of Dupuytren's Disease, sponsored by Stony Brook University.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT00260429: Completed Phase 3 study of Dupuytren's Disease, sponsored by Stony Brook University.
NCT00260429 is a Phase 3 study of Dupuytren's Disease that has completed, run by Stony Brook University. The registered enrollment target is 38 participants, below the 53-participant average among 4 other Dupuytren's Disease trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00260429, a Phase 3 study of Dupuytren's Disease, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease. 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 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Primary Outcome
The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less. The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
Conditions Studied
Interventions
- BIOLOGICAL collagenase clostridium histolyticum
Study Locations (1)
New York
- Stony Brook University Hospital and Mediacl Center - Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2003-06 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00260429 record still lists
NCT00260429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 53-participant average among 4 other Dupuytren's Disease trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Dupuytren's Disease appearing as the primary indexed condition, and to 1 intervention - of which collagenase clostridium histolyticum is the first listed.
NCT00260429 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00260429 about?
NCT00260429 is a clinical study titled "Collagenase in the Treatment of Dupuytrens Disease". The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease. 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...
What is the current status of trial NCT00260429?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2003-06. Estimated completion is 2008-04.
What conditions does trial NCT00260429 study?
This clinical trial studies the following conditions: Dupuytren's Disease.
What interventions are being tested in trial NCT00260429?
The interventions under investigation include: collagenase clostridium histolyticum (BIOLOGICAL).
Who is sponsoring clinical trial NCT00260429?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00260429 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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