Phase 4
N=52
Retreatment of Recurrent Dupuytren's Contractures
Dupuytren's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01498640 ↗Enrolled (actual)
52
Serious AEs
7.7%
Results posted
Feb 2015
Primary outcome: Primary: Clinical Success — 64.5; 45.0 percentage of particpants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Collagenase clostridium histolyticum (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success |
64.5; 45.0 | — |
| PRIMARY Percent Change From Baseline in Degree of Contracture |
83.24; 69.10 | — |
| PRIMARY Change in Range of Motion |
31.4; 26.8 | — |
| SECONDARY Physician Global Assessment of Improvement |
18; 12; 11; 5; 0; 2 | — |
| SECONDARY Subject Global Assessment of Satisfaction |
20; 10; 9; 5; 1; 2 | — |
| SECONDARY Recurrence of Contracture |
6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent
- Be currently participating in the AUX-CC-860 follow-up study
- 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
- Be able to comply with the study visit schedule as specified in the protocol
Exclusion Criteria
- Is a pregnant or lactating female or female intending to become pregnant during the study
- Has hypersensitivity to AA4500 or any of the AA4500 excipients
- 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
Data sourced from ClinicalTrials.gov (NCT01498640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.