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Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures

NCT01674634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2017-10-05

Study results available
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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.

Conditions

  • Dupuytren's Contracture

Interventions

BIOLOGICAL

XIAFLEX / XIAPEX

injection (0.58 mg after reconstitution with sterile diluent \[0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride\])

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Veronica Urdaneta, MD, MPPH · Endo Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674634 on ClinicalTrials.gov