Phase 4
Completed N=52
Retreatment of Recurrent Dupuytren's Contractures
Dupuytren's Disease
Source: ClinicalTrials.gov NCT01498640 ↗
Enrolled (actual)
52
Serious AEs
7.7%
Results posted
Feb 2015
Primary outcomePrimary: Clinical Success — 64.5; 45.0 percentage of particpants
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.
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 | — |
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. Informational only — not medical advice.