Collagenase in the Treatment of Dupuytrens Disease
This study has been completed.
Sponsor:
Stony Brook University
Collaborators:
Biospecifics Technologies Corp.
Auxilium Pharmaceuticals
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00260429
First received: November 29, 2005
Last updated: November 5, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dupuytren's Disease |
Biological: collagenase clostridium histolyticum |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Stony Brook University:
Primary Outcome Measures:
- Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint. [ Time Frame: 30 days after the last injection ] [ Designated as safety issue: No ]
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:
- Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: 30 days after last treatment to the primary joint ] [ Designated as safety issue: No ]
- Percent Change From Baseline Range of Motion After the Last Injection [ Time Frame: 30 days after last treatment to the primary joint ] [ Designated as safety issue: No ]
- Time to First Achieve and Maintain Clinical Success After the Last Injection [ Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint ] [ Designated as safety issue: No ]
- Clinical Success After the First Injection [ Time Frame: 30 days after first treatment to the primary joint ] [ Designated as safety issue: No ]
- Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: 30 days after first treatment to the primary joint ] [ Designated as safety issue: No ]
- Change From Baseline Range of Motion After the First Injection [ Time Frame: 30 days after first treatment to the primary joint ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | June 2003 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AA4500 0.58 mg |
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.
Other Names:
|
| Placebo Comparator: placebo |
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.
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260429
Locations
| United States, New York | |
| Stony Brook University Hospital and Mediacl Center | |
| Stony Brook, New York, United States, 11794 | |
Sponsors and Collaborators
Stony Brook University
Biospecifics Technologies Corp.
Auxilium Pharmaceuticals
Investigators
| Principal Investigator: | Lawrence C Hurst, MD | Stony Brook University |
More Information
Additional Information:
Publications:
| Responsible Party: | James Tursi, MD; VP of Clinical Development, Auxilium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00260429 History of Changes |
| Other Study ID Numbers: | DUPY 303 |
| Study First Received: | November 29, 2005 |
| Results First Received: | November 5, 2010 |
| Last Updated: | November 5, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Stony Brook University:
|
Dupuytren's contracture fixed flexion contracture |
Additional relevant MeSH terms:
|
Dupuytren Contracture Contracture Muscular Diseases Musculoskeletal Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 19, 2013