Dupuytren's Disease Clinical Trial
Official title:
Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
Verified date | September 2017 |
Source | Endo Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Endo Pharmaceuticals |
United States, Australia, Sweden, United Kingdom,
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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