17 completed, 1 active not recruiting, 1 unknown. 6 Phase 3, 5 Phase 2, 4 Phase 4, 1 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 6 |
| Phase 2 | 5 | Completed 5 |
| Phase 4 | 4 | Completed 2, Active not recruiting 1, Unknown 1 |
| Not applicable | 1 | Completed 1 |
| Phase 1 | 1 | Completed 1 |
Follow xiapex: new trials by email Literature Review of xiapex trials Research Report on xiapex
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 |
|---|---|---|---|---|---|---|
| Trial Comparing Treatment Strategies in Dupuytren's Contracture Percutaneous needle fasciotomy (PNF), Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex], Limited fasciectomy (LF) - Dupuytren Contracture | Phase 4 | Active not recruiting | Tampere University | 302 | 2017-09-15 | 2026-04-29 |
| Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease Xiapex - Dupuytren Contracture | Completed | Jeppe Lange | 199 | 2017-01-01 | 2020-04-22 | |
| Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture xiapex, percutaneous needle fasciotomy - Dupuytrens Contracture | Phase 4 | Unknown | Oslo University Hospital | 50 | 2015-04-01 | 2015-06-19 |
| 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 |
| 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 |
| Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF Xiapex, Needle aponeurotomy - Dupuytren Contracture | Phase 4 | Completed | University Hospital, Akershus | 80 | 2013-10-01 | 2022-04-26 |
| 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 |
| Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures XIAFLEX / XIAPEX - Dupuytren's Contracture | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 715 | 2012-09-01 | 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 |
| Collagenase Option for Reduction of Dupuytren's Contracture in Japan Collagenase Clostridium Histolyticum - Dupuytren's Contracture | Phase 3 | Completed | Asahi Kasei Therapeutics Corporation | 104 | 2012-05-01 | 2017-03-21 |
| 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 |
| Post Approval Commitment Study Xiapex, surgery - Dupuytren's Contracture | Completed | Endo USA Inc., a Keenova Therapeutics Company | 305 | 2012-03-01 | 2017-10-26 | |
| Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture Xiapex, Percutaneous needle fasciotomy - Dupuytrens Contracture | Not applicable | Completed | Jeppe Lange, MD | 50 | 2012-02-01 | 2016-10-04 |
| The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) COLLAGENASE CLOSTRIDIUM HISTOLYTICUM - Edematous Fibrosclerotic Panniculopathy, Cellulite | Phase 1 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 99 | 2012-01-01 | 2015-03-19 |
| AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder AA4500 0.29 mg/1 mL, AA4500 0.58 mg/2 mL, AA4500 0.58 mg/1 mL - Adhesive Capsulitis, Frozen Shoulder | Phase 2 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 50 | 2011-11-01 | 2017-10-05 |
| Administration of Two Injections for Multiple Dupuytren's Contractures AA4500 collagenase clostridium histolyticum - Dupuytren's Contracture | Phase 3 | Completed | Endo USA Inc., a Keenova Therapeutics Company | 60 | 2011-09-01 | 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 |
| Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) Xiapex - Dupuytren's Contracture | Phase 3 | Completed | Pfizer | 254 | 2010-12-01 | 2014-03-17 |
Dupuytren Contracture (12) · Contracture (3) · Penile Induration (3) · Bursitis (2) · Cellulite (2) · Connective Tissue Diseases (1) · Shoulder Pain (1)
Endo USA Inc., a Keenova Therapeutics Company (12) · Asahi Kasei Therapeutics Corporation (1) · Jeppe Lange (1) · Jeppe Lange, MD (1) · Oslo University Hospital (1) · Pfizer (1) · Tampere University (1) · University Hospital, Akershus (1)
United States (9) · Australia (4) · Norway (3) · United Kingdom (3) · Denmark (2) · Spain (2) · Sweden (2) · Finland (1) · France (1) · Germany (1) · Hungary (1) · Italy (1) · Japan (1)
Veronica Urdaneta, MD MPH (3) · Veronica Urdaneta, MD, MPPH (3) · Aleksi RP Reito, M.D., Ph.D., adjunct professor (1) · Antti OV Malmivaara, M.D., Ph.D., adjunct professor (1) · Charlotte Hartig-Andreasen, MD, PhD (1) · Gregory J. Kaufman, MD (1) · Gregory Kaufman, MD (1) · Hannu Kautiainen, MSc (1) · Jeppe Lange, M.D. (1) · Neil H Schusterman, MD FACP (1) · Neil H Shusterman, MD FACP (1) · Neil Shusterman, MD (1) · Per-Henrik Randsborg, PhD (1)
PMID 24470559, PMID 27313184, PMID 28854973, PMID 28974406, PMID 30722822, PMID 38346307, PMID 41334972