Dupuytren's Disease Clinical Trial
Official title:
A Phase 2a, Double-blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Effectiveness of AA4500 in the Treatment of Dupuytren's Disease Nodules
The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.
Approximately 13 sites in the United States and Australia, approximately 90 study subjects.
After all pre-injection procedures are completed on day 1, eligible men and women will be
randomized in a 1:1:1 ratio to dose group and then in a 4:1 ratio to treatment group. Study
drug will be administered into a palmar nodule located on the selected hand.
AA4500 (collagenase clostridium histolyticum) 3 doses (low, medium, and high) after
reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium
chloride). Each dose of study drug will be injected into the nodule. The injection will be
administered in 3 different volumes according to randomization.
Placebo after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in
0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The
injection will be administered in 3 different volumes according to randomization.
Follow up visits for the evaluation of safety and efficacy will be required for all subjects
on days 8, 29, and 57.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05300893 -
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
|
N/A | |
| Recruiting |
NCT04122313 -
Post-contracture Release Radiation for Dupuytren's Disease
|
||
| Completed |
NCT01498640 -
Retreatment of Recurrent Dupuytren's Contractures
|
Phase 4 | |
| Completed |
NCT01450397 -
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
|
Phase 4 | |
| Completed |
NCT03180957 -
Repurposing Anti-TNF for Treating Dupuytren's Disease
|
Phase 2 | |
| Completed |
NCT00575458 -
Splinting for Dupuytren's Contracture Release
|
N/A | |
| Completed |
NCT00260429 -
Collagenase in the Treatment of Dupuytrens Disease
|
Phase 3 | |
| Recruiting |
NCT05067764 -
Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease
|
N/A | |
| Completed |
NCT02725528 -
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
|
Phase 3 | |
| Completed |
NCT00954746 -
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
|
N/A | |
| Completed |
NCT04874870 -
Effectiveness of Splinting After Collagenase Injection
|
Phase 3 | |
| Recruiting |
NCT06263699 -
Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease
|
||
| Not yet recruiting |
NCT02294890 -
Knee Stiffness in Fibrosis Diathesis
|
N/A | |
| Completed |
NCT04669704 -
Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.
|
N/A | |
| Recruiting |
NCT05440240 -
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
|
Phase 4 | |
| Recruiting |
NCT06142929 -
Micronerves in Dupuytren and the Impact of Its Dissection on Recurrence
|
||
| Active, not recruiting |
NCT01446432 -
Validation of Two New Questionnaires for Dupuytren's Disease
|
N/A | |
| Recruiting |
NCT06281509 -
Palmaris Longus Muscle and Dupuytren
|
N/A | |
| Recruiting |
NCT06321991 -
Nodular Shrinking in Dupuytren Disease
|
Phase 2 | |
| Completed |
NCT01567397 -
Registry of Dupuytren's Contracture Treatment Outcomes
|
N/A |