AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

Dupuytren's Contracture Clinical Trial

— CORD-I  

Official title:

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528606
• Other study ID #: AUX-CC-857
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2007
• Last updated: October 26, 2017
• Start date: August 2007
• Est. completion date: April 2008

Study information

• Verified date: October 2017
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.

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 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had never been treated with AA4500.

• Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.

• Judged to be in good health.

Exclusion Criteria:

• Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.

• Had received a treatment for Dupuytren's contracture, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.

• Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Contracture

Intervention

Biological:
• collagenase clostridium histolyticum
Subjects could have received up to three injections of AA4500 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
Subjects could have received up to three injections of 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	The Hand and Upper Extremity Center of Georgia, P.C.	Atlanta	Georgia
United States	Brigham and Women's Hospital, Department of Orthopedic Surgery	Boston	Massachusetts
United States	Hand Surgery Associates, PC	Denver	Colorado
United States	Hand Microsurgery & Reconstructive Orthopaedics	Erie	Pennsylvania
United States	The Indiana Hand Center	Indianapolis	Indiana
United States	100 UCLA Medical Plaza, Suite 305	Los Angeles	California
United States	TRIA Orthopaedic Center	Minneapolis	Minnesota
United States	Hospital for Special Surgery	New York	New York
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Hand Surgery Clinic	Palo Alto	California
United States	Department of Orthopaedics, Brown University, Rhode Island Hospital	Providence	Rhode Island
United States	Rockford Orthopedic Associates, Ltd.	Rockford	Illinois
United States	University Orthopedics Center	State College	Pennsylvania
United States	SUNY Stony Brook - Department of Orthopedics	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection	The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.; The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.	Within 30 days after the last injection
Secondary	Clinical Improvement After the Last Injection	Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection.	Baseline; within 30 days after the last injection
Secondary	Percent Reduction From Baseline Contracture After the Last Injection	Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.	Baseline; within 30 days after the last injection
Secondary	Change From Baseline Range of Motion After the Last Injection	Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.	Baselin; within 30 days after the last injection
Secondary	Time to First Achieve Success After the Last Injection		Last evaluation visit on which clinical success is achieved through the Day 30 evaluation
Secondary	Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection	Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.	Within 30 days after first injection
Secondary	Clinical Improvement After the First Injection	Clinical Improvement is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.	Baseline; within 30 days after the first injection
Secondary	Percent Reduction From Baseline Contracture After the First Injection	Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.	Baseline, within 30 days after the first injection
Secondary	Change From Baseline Range of Motion After the First Injection	Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.	Baseline; within 30 days after the first injection

External Links

•   XIAFLEX Medication Guide
•   XIAFLEX Prescribing Information