Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
Public ClinicalTrials.gov record NCT01674634. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3b Open-label, Historically-controlled Study to Assess the Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures With Palpable Cords
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01674634
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 715 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2012 (Type not available)
- Primary completion
- Jul 2013 (Actual)
- Completion
- Jul 2013 (Actual)
- Last update posted
- Oct 5, 2017
2012 – 2013
United States locations
- U.S. sites
- 25
- U.S. states
- 19
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85018 | — |
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | — |
| CORE Orthopaedic Medical Center | Encinitas | California | 92024 | — |
| Torrey Pines Medical Group | La Jolla | California | 92037 | — |
| Brigid Freyne, MD, Inc. | Murrieta | California | 92563 | — |
| The Hand and Upper Extremity Center | Atlanta | Georgia | 30342 | — |
| Rockford Orthopedic Associates | Rockford | Illinois | 61107 | — |
| The Indiana Hand to Shoulder Center | Indianapolis | Indiana | 46260 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Christine M. Kleinert Institute for Hand and Microsurgery, Inc. | Louisville | Kentucky | 40202 | — |
| Lake Cumberland Rheumatology | Somerset | Kentucky | 42503 | — |
| TRIA Orthopedic Center | Minneapolis | Minnesota | 55431 | — |
| Missoula Bone and Joint | Missoula | Montana | 59808 | — |
| Nevada Orthopedic and Spine Center | Las Vegas | Nevada | 89128 | — |
| Central Jersey Hand Surgery | Eatontown | New Jersey | 07724 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| SUNY Stony Brook | Setauket | New York | 11733 | — |
| UNC School of Medicine | Chapel Hill | North Carolina | 27599 | — |
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | 28207 | — |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | — |
| The Center for Neurosurgical and Orthopedic Care and Research | Bend | Oregon | 97701 | — |
| Hand Microsurgery & Reconstructive Orthopaedics | Erie | Pennsylvania | 16507 | — |
| Alpha Clinical Research, LLC | Clarksville | Tennessee | 37043 | — |
| Accurate Clinical Research, Inc. | Houston | Texas | 77034 | — |
| The Arthritis Clinic of Northern Virginia, PA | Arlington | Virginia | 22205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01674634, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2017 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01674634 live on ClinicalTrials.gov.