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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Dupuytren's Contracture

Treatments

Drug: Xiapex

Study type

Interventional

Funder types

Industry

Identifiers

NCT01229436

B1531002

Details and patient eligibility

About

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).

Enrollment

254 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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