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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Dupuytren's Contracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xiapex Injection

Group Type EXPERIMENTAL

Xiapex

Intervention Type DRUG

Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol

Interventions

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Xiapex

Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No