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Retreatment of Recurrent Dupuytren's Contractures

NCT ID: NCT01498640

Last Updated: 2017-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

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The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.

Detailed Description

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Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.

Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

Conditions

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Dupuytren's Disease

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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XIAFLEX/XIAPEX MP Joint

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord

Group Type EXPERIMENTAL

Collagenase clostridium histolyticum

Intervention Type BIOLOGICAL

up to three 0.58 mg injections

XIAFLEX/XIAPEX PIP Joint

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord

Group Type EXPERIMENTAL

Collagenase clostridium histolyticum

Intervention Type BIOLOGICAL

up to three 0.58 mg injections

Interventions

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Collagenase clostridium histolyticum

up to three 0.58 mg injections

Intervention Type BIOLOGICAL

Other Intervention Names

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XIAFLEX XIAPEX AA4500

Eligibility Criteria

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Inclusion Criteria

1. Provide written informed consent
2. Be currently participating in the AUX-CC-860 follow-up study
3. Have at least one joint with all of the following:

* The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
* The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
* A palpable cord is present in the joint to be treated
4. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria

1. Is a pregnant or lactating female or female intending to become pregnant during the study
2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs \[NSAIDs\]) within 7 days before injection of AA4500
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronica Urdaneta, MD, MPPH

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

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HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Rockford Orthopedic Associates

Rockford, Illinois, United States

Site Status

The Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Site Status

Marquette General Health System

Marquette, Michigan, United States

Site Status

East River Professional Building

New York, New York, United States

Site Status

Health Reserarch Institute

Oklahoma City, Oklahoma, United States

Site Status

Hand Microsurgery and Reconstructive Orthopaedics

Erie, Pennsylvania, United States

Site Status

Peninsula Private Hospital

Kippa-Ring, Queensland, Australia

Site Status

AusTrials Sherwood

Sherwood, Queensland, Australia

Site Status

Emeritus Research

Malvern East, Victoria, Australia

Site Status

Uppsala Akademiska University Hospital

Uppsala, SE, Sweden

Site Status

Pulvertaft Hand Center

Derby, GB, United Kingdom

Site Status

Newcastle Upon Tyne Hospitals

Newcastle, GB, United Kingdom

Site Status

Countries

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United States Australia Sweden United Kingdom

Other Identifiers

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AUX-CC-862

Identifier Type: -

Identifier Source: org_study_id