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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01498640
Other study ID # AUX-CC-862
Secondary ID
Status Completed
Phase Phase 4
First received December 17, 2011
Last updated September 7, 2017
Start date March 2012
Est. completion date October 2013

Study information

Verified date September 2017
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Collagenase clostridium histolyticum
up to three 0.58 mg injections

Locations

Country Name City State
Australia Peninsula Private Hospital Kippa Ring Queensland
Australia Emeritus Research Malvern East Victoria
Australia AusTrials Sherwood Sherwood Queensland
Sweden Uppsala Akademiska University Hospital Uppsala SE
United Kingdom Pulvertaft Hand Center Derby GB
United Kingdom Newcastle Upon Tyne Hospitals Newcastle GB
United States Hand Microsurgery and Reconstructive Orthopaedics Erie Pennsylvania
United States The Indiana Hand to Shoulder Center Indianapolis Indiana
United States Marquette General Health System Marquette Michigan
United States East River Professional Building New York New York
United States Health Reserarch Institute Oklahoma City Oklahoma
United States HOPE Research Institute Phoenix Arizona
United States Rockford Orthopedic Associates Rockford Illinois

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Success Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500 30 days after last injection
Primary Percent Change From Baseline in Degree of Contracture Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees Baseline and 30 days after last injection
Primary Change in Range of Motion Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees Baseline and 30 days after last injection
Secondary Physician Global Assessment of Improvement Physician global assessment of change (improvement) in subject's Dupuytren's contracture 30 days after last injection
Secondary Subject Global Assessment of Satisfaction Subject global assessment of overall treatment satisfaction 30 days after last injection
Secondary Recurrence of Contracture Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points. Day 365
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