Clinical Trials Directory

Trials / Completed

CompletedNCT01265420

Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Indiana Hand to Shoulder Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.

Conditions

Interventions

TypeNameDescription
BIOLOGICALInjectable clostridial collagenaseInjection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections

Timeline

Start date
2010-12-01
Primary completion
2014-02-01
Completion
2014-02-01
First posted
2010-12-23
Last updated
2015-04-30
Results posted
2015-04-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01265420. Inclusion in this directory is not an endorsement.

Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb (NCT01265420) · Clinical Trials Directory