18 completed. 10 Phase 3, 6 Phase 2, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 10 |
| Phase 2 | 6 | Completed 6 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow AA4500: new trials by email Literature Review of AA4500 trials Research Report on AA4500
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease AA4500, ErecAid® Esteem® Manual Vacuum Therapy System, Investigator Modeling - Peyronie's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 30 | 2014-10-01 | 2017-11-08 |
| Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma AA4500, placebo - Lipoma | Phase 2 | Completed | Gerut, Zachary, M.D. | 19 | 2014-08-01 | 2017-02-23 |
| Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules Collagenase clostridium histolyticum, Placebo - Dupuytren's Disease | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 76 | 2014-07-01 | 2017-10-05 |
| Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder Collagenase Clostridium Histolyticum, Placebo - Adhesive Capsulitis, Frozen Shoulder | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 322 | 2013-11-01 | 2017-10-05 |
| A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy Collagenase Clostridium Histolyticum, Placebo - Edematous Fibrosclerotic Panniculopathy (EFP) | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 150 | 2013-10-01 | 2017-10-05 |
| A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease AA4500 - Peyronie's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 189 | 2012-09-01 | 2017-10-05 |
| Retreatment of Recurrent Dupuytren's Contractures Collagenase clostridium histolyticum - Dupuytren's Disease | Phase 4 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 52 | 2012-03-01 | 2017-10-05 |
| Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease AA4500 - Peyronie's Disease | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 20 | 2011-09-01 | 2017-10-05 |
| A Study of AA4500 in Men With Peyronie's Disease AA4500 - Peyronie's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 348 | 2010-11-01 | 2017-10-05 |
| Study of AA4500 in the Treatment of Peyronie's Disease AA4500, Placebo - Peyronie's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 418 | 2010-10-01 | 2017-10-05 |
| Study of AA4500 in the Treatment of Peyronie's Disease AA4500, Placebo - Peyronie's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 418 | 2010-09-01 | 2017-10-05 |
| The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease AA4500, Placebo - Peyronie's Disease | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 147 | 2008-08-01 | 2017-10-05 |
| AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease AA4500 - Advanced Dupuytren's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 286 | 2007-12-01 | 2017-12-02 |
| Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease collagenase clostridium histolyticum - Advanced Dupuytren's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 201 | 2007-10-01 | 2017-12-02 |
| A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture collagenase clostridium histolyticum - Dupuytren's Contracture | Phase 1 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 16 | 2007-09-01 | 2017-10-05 |
| Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease collagenase clostridium histolyticum - Advanced Dupuytren's Disease | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 66 | 2007-08-01 | 2017-12-02 |
| AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture collagenase clostridium histolyticum, Placebo - Dupuytren's Contracture | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 308 | 2007-08-01 | 2017-12-02 |
| Collagenase in the Treatment of Dupuytrens Disease collagenase clostridium histolyticum - Dupuytren's Disease | Phase 3 | Completed | Stony Brook University | 38 | 2003-06-01 | 2010-12-09 |
Penile Induration (7) · Dupuytren Contracture (5) · Bursitis (1) · Cellulite (1) · Contracture (1) · Lipoma (1) · Shoulder Pain (1)
Endo USA Inc., a Keenova Therapeutics Company (16) · Gerut, Zachary, M.D. (1) · Stony Brook University (1)
United States (15) · Australia (6) · United Kingdom (3) · Sweden (2) · Denmark (1) · France (1) · Germany (1) · Italy (1) · New Zealand (1) · Spain (1)
Veronica Urdaneta, MD (6) · Gregory J. Kaufman, MD (3) · Gregory Kaufman, MD (2) · Veronica Urdaneta, MD MPH (2) · Lawrence C Hurst, MD (1) · Neil H Schusterman, MD FACP (1) · Neil Shusterman, MD (1) · Veronica Urdaneta, MD, MPPH (1) · Zachary E Gerut, MD (1)
PMID 26199168, PMID 19726771, PMID 21967070, PMID 25388099, PMID 28854973, PMID 28974406