Phase 3
N=35
Collagenase in the Treatment of Dupuytrens Disease
Dupuytren's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00260429 ↗Enrolled (actual)
35
Serious AEs
7.9%
Results posted
Dec 2010
Primary outcome: Primary: Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint. — 91.3; 0 % Joints
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- collagenase clostridium histolyticum (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stony Brook University
- Primary completion
- Aug 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint. |
91.3; 0 | — |
| SECONDARY Percent Reduction From Baseline Contracture After the Last Injection |
— | — |
| SECONDARY Percent Change From Baseline Range of Motion After the Last Injection |
— | — |
| SECONDARY Time to First Achieve and Maintain Clinical Success After the Last Injection |
— | — |
| SECONDARY Clinical Success After the First Injection |
— | — |
| SECONDARY Percent Reduction From Baseline Contracture After the First Injection |
— | — |
| SECONDARY Change From Baseline Range of Motion After the First Injection |
— | — |
Summary
The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
Eligibility Criteria
Inclusion Criteria
- Subjects were at least 18 years of age, of either sex or any race.
- Subjects had residual Dupuytren's disease with a fixed-flexion deformity of the finger(s) of at least 20 degrees or greater, caused by a palpable cord.
- Subjects had a positive "table-top test" defined as the inability to simultaneously place their affected finger(s) and palm flat against a table top.
- Subjects must have been willing to participate in and complete the study, and comply with its procedures by signing an IRB approved written consent form.
- Subjects must have been able to understand and adhere to the visit schedule. They must have been able to follow study procedures and instructions, and have agreed to report concomitant medications and adverse events accurately and consistently.
- Women of childbearing potential must have agreed to use an acceptable method of birth control or must have been surgically sterilized (hysterectomy or tubal ligation). Women of childbearing age had a urine pregnancy test on Day 0 (day of injection) prior to the injection.
Exclusion Criteria
- Women who were nursing or who were pregnant (as evidenced by a positive urine pregnancy test at the time of enrollment).
- Subjects who had participated in an investigational drug trial within 30 days of enrollment in this study.
- Subjects who had received surgery for Dupuytren's disease within 30 days of enrollment in this study.
- Subjects who had a known allergy to AA4500 or any of the inactive ingredients in the AA4500 injection.
- Subjects who had a known allergy to doxycycline.
- Subjects who had a medical condition that would have made them unsuitable for enrollment.
Data sourced from ClinicalTrials.gov (NCT00260429). 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.