Collagenase in the Treatment of Dupuytrens Disease

NCT00260429 | Completed Phase 3 Results

• 1 other identifier: DUPY 303
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren's Disease

Keywords

Dupuytren's contracture; fixed flexion contracture

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

AA4500 0.58 mg

EXPERIMENTAL

Biological: collagenase clostridium histolyticum

placebo

PLACEBO COMPARATOR

Biological: collagenase clostridium histolyticum

Interventions

collagenase clostridium histolyticum 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.

Also known as: XIAFLEX®, AA4500

AA4500 0.58 mg; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead
• Biospecifics Technologies Corp.: collaborator
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Stony Brook University Hospital and Mediacl Center

Stony Brook, New York, 11794, United States

Location

Related 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. doi: 10.1053/jhsu.2002.35299.

  PMID: 12239666 BACKGROUND

Related Links

• XIAFLEX Prescribing Information

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Greg Kaufman, MD; Senior Director of Clinical Development
• Organization: Auxilium Pharmaceuticals, Inc.

gkaufman@auxilium.com

484 321 5900

Study Officials

• Lawrence C Hurst, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: June 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: April 1, 2008
• Last Updated: December 9, 2010
• Results First Posted: December 9, 2010

Record last verified: 2010-11

Locations

US (1)