Collagenase in the Treatment of Dupuytrens Disease

Dupuytren's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260429
• Other study ID #: DUPY 303
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2005
• Last updated: November 5, 2010
• Start date: June 2003
• Est. completion date: April 2008

Study information

• Verified date: November 2010
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2008
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease

Intervention

Biological:
• collagenase clostridium histolyticum
Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital and Mediacl Center	Stony Brook	New York

Sponsors (3)

Lead Sponsor	Collaborator
Stony Brook University	Biospecifics Technologies Corp., Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.	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.	30 days after the last injection	No
Secondary	Percent Reduction From Baseline Contracture After the Last Injection		30 days after last treatment to the primary joint	No
Secondary	Percent Change From Baseline Range of Motion After the Last Injection		30 days after last treatment to the primary joint	No
Secondary	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	No
Secondary	Clinical Success After the First Injection		30 days after first treatment to the primary joint	No
Secondary	Percent Reduction From Baseline Contracture After the First Injection		30 days after first treatment to the primary joint	No
Secondary	Change From Baseline Range of Motion After the First Injection		30 days after first treatment to the primary joint	No

External Links

•   XIAFLEX Medication Guide
•   XIAFLEX Prescribing Information