Status:
COMPLETED
Collagenase in the Treatment of Dupuytrens Disease
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
Biospecifics Technologies Corp.
Endo Pharmaceuticals
Conditions:
Dupuytren's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 larg...
Detailed Description
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord. Resultant cord disruption may obviate the nee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00260429
Start Date
June 1 2003
End Date
April 1 2008
Last Update
December 9 2010
Active Locations (1)
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1
Stony Brook University Hospital and Mediacl Center
Stony Brook, New York, United States, 11794