Phase 4
N=5
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Dupuytren's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01450397 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. — 482 mm^3 — p=<0.0013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- XIAFLEX (Biological)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. |
482 | <0.0013 sig |
Summary
The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.
Eligibility Criteria
Inclusion Criteria
- Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
- Subject has only one finger affected by the disease.
- Patients will be 35 years of age of older.
- Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.
Exclusion Criteria
- Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
- Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
- Patient has known allergy to collagenase or any other excipient of Xiaflex.
- Patient has received any collagenase treatments before the first dose of Xiaflex.
- Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.
Data sourced from ClinicalTrials.gov (NCT01450397). 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.