Clinical trial NCT00260429: Collagenase in the Treatment of Dupuytrens Disease
Official title: Double-blind, Randomized Placebo Controlled Study of the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of Residual-type Dupuytren's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dupuytren's Disease
Keywords: Dupuytren's contracture
fixed flexion contracture
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Biospecifics Technologies Corp.
name: Endo Pharmaceuticals
First posted: 2005-12-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.

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.

Primary outcomes:
measure: Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.
timeFrame: 30 days after the last injection
Secondary outcomes:
measure: Percent Reduction From Baseline Contracture After the Last Injection
timeFrame: 30 days after last treatment to the primary joint
measure: Percent Change From Baseline Range of Motion After the Last Injection
timeFrame: 30 days after last treatment to the primary joint
measure: Time to First Achieve and Maintain Clinical Success After the Last Injection
timeFrame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint
measure: Clinical Success After the First Injection
timeFrame: 30 days after first treatment to the primary joint
measure: Percent Reduction From Baseline Contracture After the First Injection
timeFrame: 30 days after first treatment to the primary joint
measure: Change From Baseline Range of Motion After the First Injection
timeFrame: 30 days after first treatment to the primary joint
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital and Mediacl Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Lawrence C Hurst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg Am. 2002 Sep;27(5):788-98. doi: 10.1053/jhsu.2002.35299.