Dupuytren's Contracture Clinical Trial
Official title:
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture
This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the
United States. Subjects with a diagnosis of Dupuytren's 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 2:1 to receive AA4500 0.58 mg or
placebo.
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 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7
non-pivotal studies were evaluated.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01674634 -
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
|
Phase 3 | |
Completed |
NCT01715467 -
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
|
N/A | |
Completed |
NCT01407068 -
Administration of Two Injections for Multiple Dupuytren's Contractures
|
Phase 3 | |
Completed |
NCT00528931 -
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
|
Phase 1 | |
Completed |
NCT00565019 -
Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
|
Phase 3 | |
Completed |
NCT01588353 -
Collagenase Option for Reduction of Dupuytren's Contracture in Japan
|
Phase 3 | |
Completed |
NCT00468949 -
Health-Related Quality of Life in Patients With Dupuytren's Disease
|
Phase 1 | |
Completed |
NCT01444729 -
Post Approval Commitment Study
|
N/A | |
Terminated |
NCT05877066 -
Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
|
||
Completed |
NCT01229436 -
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
|
Phase 3 | |
Completed |
NCT01265420 -
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
|
Phase 4 | |
Completed |
NCT00931567 -
Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing
|
Phase 2/Phase 3 | |
Completed |
NCT00004409 -
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
|
Phase 2 | |
Completed |
NCT00014742 -
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
|
Phase 3 |