Clinical Trials Logo

Clinical Trial Summary

The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02193828
Study type Interventional
Source Endo Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date July 2014
Completion date December 2014

See also
  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
Active, not recruiting 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
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
Not yet recruiting NCT06142929 - Micronerves in Dupuytren and the Impact of Its Dissection on Recurrence
Completed NCT01567397 - Registry of Dupuytren's Contracture Treatment Outcomes N/A