Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014742
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2001-04-10
Brief Title:
Phase III Randomized Study of Collagenase in Patients With Residual Stage 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:
2001-04
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 I Compare the safety and efficacy of clostridial collagenase vs placebo in terms of improving the degree of flexion deformity range of finger motion and grip strength in patients with residual stage Dupuytrens disease
II Compare the overall clinical success rate time to return to normal finger contracture to within 0-5 degrees of normal zero degrees and frequency of cord rupture in the joint of patients treated with these regimens
III Compare the baseline change in degree of finger flexion deformity range of motion of the treated finger and strength of hand grip in pounds in patients treated with these regimens
IV Compare the frequency distribution of the number of patients with reduction in finger contracture to within 0-5 degrees of normal zero degrees and the number who require re-treatment with open-label collagenase after treatment with these regimens
II Compare the overall clinical success rate time to return to normal finger contracture to within 0-5 degrees of normal zero degrees and frequency of cord rupture in the joint of patients treated with these regimens
III Compare the baseline change in degree of finger flexion deformity range of motion of the treated finger and strength of hand grip in pounds in patients treated with these regimens
IV Compare the frequency distribution of the number of patients with reduction in finger contracture to within 0-5 degrees of normal zero degrees and the number who require re-treatment with open-label collagenase after treatment with these regimens
Detailed Description:
PROTOCOL OUTLINE This is a randomized investigator-blinded placebo-controlled multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive a single collagenase injection into the target finger cord on day 0
Arm II Patients receive a single placebo injection as in arm I
Both arms After the 1 month evaluation patients who are unresponsive to treatment may receive monthly injections of collagenase for a maximum of 5 injections
Beginning at 1 day after completion of treatment patients use a joint nighttime extension splint for 4 months and perform finger flexionextension exercises
Patients are followed at 1 7 and 14 days monthly for 3 months every 3 months for 9 months and then annually for 4 years
Completion date provided represents the completion date of the grant per OOPD records
Arm I Patients receive a single collagenase injection into the target finger cord on day 0
Arm II Patients receive a single placebo injection as in arm I
Both arms After the 1 month evaluation patients who are unresponsive to treatment may receive monthly injections of collagenase for a maximum of 5 injections
Beginning at 1 day after completion of treatment patients use a joint nighttime extension splint for 4 months and perform finger flexionextension exercises
Patients are followed at 1 7 and 14 days monthly for 3 months every 3 months for 9 months and then annually for 4 years
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-FDR001437 | None | None | None |