Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004409
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytrens Disease
Sponsor:
State University of New York
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-05
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:
OBJECTIVES
Evaluate the safety and efficacy of collagenase in improving flexion deformity range of motion and grip strength in patients with residual Dupuytrens disease
Evaluate the safety and efficacy of collagenase in improving flexion deformity range of motion and grip strength in patients with residual Dupuytrens disease
Detailed Description:
PROTOCOL OUTLINE This is a randomized investigator-blinded placebo-controlled study
Patients receive a single dose of either collagenase or placebo into the target finger on day 0 Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase if IgE antibody levels are no greater than 15 ngmL
Following treatment patients use a nighttime extension splint for 4 months and perform finger flexionextension exercises Patients are followed at 1 7 and 14 days and at 1 2 3 6 9 and 12 months for each joint treated
Completion date provided represents the completion date of the grant per OOPD records
Patients receive a single dose of either collagenase or placebo into the target finger on day 0 Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase if IgE antibody levels are no greater than 15 ngmL
Following treatment patients use a nighttime extension splint for 4 months and perform finger flexionextension exercises Patients are followed at 1 7 and 14 days and at 1 2 3 6 9 and 12 months for each joint treated
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SUNY-SB-431-X2020 | None | None | None |
| SUNY-SB-FDR001373 | None | None | None |
| DUPY-101 | None | None | None |
| DUPY-202 | None | None | None |
| SUNY-SB-431-1007A | None | None | None |
| SUNY-SB-431-8804B | None | None | None |