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Enzyme

XIAFLEX / XIAPEX for Dupuytren's Contracture

Phase 3
Waitlist Available
Research Sponsored by Endo Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 61
Awards & highlights

Summary

The primary objective of this study is to assess the safety of two concurrent injections of AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of occurrence of targeted serious adverse events (tendon rupture/ligament injury and anaphylaxis) to historical rates of the same in clinical studies and post-marketing commercial use. The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.

Eligible Conditions
  • Dupuytren's Contracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 61
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 61 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Total Range of Motion
Percent Change From Baseline in Total Fixed Flexion
Secondary outcome measures
Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31
Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61
Clinical Improvement
+5 more

Side effects data

From 2013 Phase 3 trial • 715 Patients • NCT01674634
77%
Oedema peripheral
59%
Contusion
50%
Pain in extremity
26%
Laceration
15%
Pruritus
14%
Injection site pain
13%
Lymphadenopathy
12%
Blood blister
8%
Injection site haematoma
7%
Axillary pain
6%
injection site haemorrhage
6%
Injection site swelling
5%
Ecchymosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
XIAFLEX/XIAPEX

Trial Design

1Treatment groups
Experimental Treatment
Group I: XIAFLEX / XIAPEXExperimental Treatment1 Intervention
AA4500 (collagenase clostridium histolyticum)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Collagenase clostridium histolyticum
FDA approved

Find a Location

Who is running the clinical trial?

Endo PharmaceuticalsLead Sponsor
133 Previous Clinical Trials
32,446 Total Patients Enrolled
Veronica Urdaneta, MD, MPPHStudy DirectorEndo Pharmaceuticals
2 Previous Clinical Trials
112 Total Patients Enrolled
~55 spots leftby Sep 2025
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