At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
AA4500 collagenase clostridium histolyticumbiological
Likely dose
AA4500 collagenase clostridium histolyticum 0.58 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study to Assess the Safety and Efficacy of Concurrent Administration of Two Injections of AA4500 0.58 mg Into the Same Hand of Subjects With Multiple Dupuytren's Contractures
In Brief
A Phase 3 clinical trial evaluating AA4500 collagenase clostridium histolyticum for Dupuytren's Contracture. Completed, enrolled 60 participants across 8 sites in 2 countries.
Detailed Summary
The objectives of this study are to assess the safety and efficacy of concurrent administration of two injections of AA4500 into the same hand of subjects with multiple Dupuytren's contractures caused by palpable cords.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDupuytren's Contracture
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartSep 2011
Primary CompletionFeb 2012
TodayJul 2026
First PostedAug 1, 2011
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.9 years ago
Interventions
AA4500 collagenase clostridium histolyticumbiological
2 concurrent injections (0.58 mg) into 2 cords on the same hand