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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. 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.
Interventions
- BIOLOGICAL XIAFLEX / XIAPEX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01674634
The ClinicalTrials.gov registry entry for NCT01674634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 715 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which XIAFLEX / XIAPEX is the first listed.
NCT01674634 reports 0 study locations.
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.
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