Overview

Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)

Status:
Completed

Trial end date:
2012-10-01

Target enrollment:
0

Participant gender:
All

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 their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Criteria

Inclusion Criteria:

- 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 Criteria:

- 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