Status:
COMPLETED
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
Lead Sponsor:
Pfizer
Conditions:
Dupuytren's Contracture
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and thei...
Eligibility Criteria
Inclusion
- Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
- Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Exclusion
- Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure
- On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection
- Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT01229436
Start Date
December 1 2010
End Date
October 1 2012
Last Update
March 17 2014
Active Locations (28)
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1
Pfizer Investigational Site
Copenhagen, Denmark, 1402 K
2
Pfizer Investigational Site
Silkeborg, Denmark, 8600
3
Pfizer Investigational Site
Montpellier, France, 34295
4
Pfizer Investigational Site
Nice, France, 06000