Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00528606
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2007-09-11
Brief Title:
AA4500 XIAFLEX Proposed Name in the Treatment of Dupuytrens Contracture
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Double-Blind Randomized Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytrens Contracture
Status:
COMPLETED
Status Verified Date:
2017-10
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:
CORD-I
Brief Summary:
This was a Phase 3 double-blind randomized placebo-controlled study conducted in the United States Subjects with a diagnosis of Dupuytrens contracture 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 injection were randomized 21 to receive AA4500 058 mg or placebo
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 NCT00528606 and AUX-CC-859 NCT00533273 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 NCT00528606 and AUX-CC-859 NCT00533273 and 7 non-pivotal studies were evaluated
Detailed Description:
None
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