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NCT01674634 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 715
- Enrollment target
NCT01674634: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT01674634 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 715 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01674634, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 715 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the safety of two concurrent injections of AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of occurrence of targeted serious adverse events (tendon rupture/ligament injury and anaphylaxis) to historical rates of the same in clinical studies and post-marketing commercial use. The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.
Primary Outcome
Percent change from baseline in total fixed flexion = 100 \* (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.
Interventions
- BIOLOGICAL XIAFLEX / XIAPEX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01674634 record still lists
NCT01674634 is an interventional study that assigns participants to a tested intervention. The registered 715 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which XIAFLEX / XIAPEX is the first listed.
NCT01674634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01674634 about?
NCT01674634 is a clinical study titled "Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures". The primary objective of this study is to assess the safety of two concurrent injections of AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of occurrence of targeted se...
What is the current status of trial NCT01674634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 715 participants. The study started on 2012-09. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01674634?
The interventions under investigation include: XIAFLEX / XIAPEX (BIOLOGICAL).
Who is sponsoring clinical trial NCT01674634?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01674634's enrollment target sits among peer trials
715 498th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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