Collagenase in the Treatment of Dupuytrens Disease

NCT ID: NCT00260429

Last Updated: 2010-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Dupuytren's Disease

Keywords

Dupuytren's contracture; fixed flexion contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AA4500 0.58 mg

Group Type: EXPERIMENTAL

collagenase clostridium histolyticum

Intervention Type: BIOLOGICAL

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.

placebo

Group Type: PLACEBO_COMPARATOR

collagenase clostridium histolyticum

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

XIAFLEX®; AA4500

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biospecifics Technologies Corp.

INDUSTRY

Sponsor Role: collaborator

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Auxilium Pharmaceuticals, Inc.

Principal Investigators

Lawrence C Hurst, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University Hospital and Mediacl Center

Stony Brook, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12239666 (View on PubMed)

Related Links

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf

XIAFLEX Prescribing Information

Other Identifiers

DUPY 303

Identifier Type: -

Identifier Source: org_study_id