Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260429
Status:
COMPLETED
Last Update Posted:
2010-12-09
First Post:
2005-11-29
Brief Title:
Collagenase in the Treatment of Dupuytrens Disease
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Double-blind Randomized Placebo Controlled Study of the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of Residual-type Dupuytrens Disease
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytrens disease
This study was designed to be part of the larger clinical program for adult patients with Dupuytrens 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
This study was designed to be part of the larger clinical program for adult patients with Dupuytrens 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
Detailed Description:
In a random placebo controlled double blind study collagenase injection therapy will be investigated for its ability to disrupt the Dupuytrens cord
Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytrens disease
Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytrens disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None