Collagenase in the Treatment of Dupuytrens Disease

Phase 3

Completed

• Conditions: Dupuytren's Disease
• Interventions: Biological: collagenase clostridium histolyticum

• Registration Number: NCT00260429
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-08
• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-29
• Study First Posted: 2005-12-01
• Study Completion: 2008-04
• Status Verified: 2010-11
• Results First Submitted: 2010-11-05
• Results First Submitted QC: 2010-11-05
• Last Update Submitted: 2010-11-05
• Results First Posted: 2010-12-09
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AA4500 0.58 mg	collagenase clostridium histolyticum	-
placebo	collagenase clostridium histolyticum	-

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.	30 days after the last injection	The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.; The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.

Secondary Outcome Measures

Name	Time	Method
Percent Reduction From Baseline Contracture After the Last Injection	30 days after last treatment to the primary joint
Percent Change From Baseline Range of Motion After the Last Injection	30 days after last treatment to the primary joint
Time to First Achieve and Maintain Clinical Success After the Last Injection	First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint
Clinical Success After the First Injection	30 days after first treatment to the primary joint
Percent Reduction From Baseline Contracture After the First Injection	30 days after first treatment to the primary joint
Change From Baseline Range of Motion After the First Injection	30 days after first treatment to the primary joint

Trial Locations

Locations (1)

Stony Brook University Hospital and Mediacl Center; 🇺🇸 Stony Brook, New York, United States