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Completed

NCT Number: NCT00528606

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

100 UCLA Medical Plaza, Suite 305, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collagenase Clostridium Histolyticum

Biological

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.

Other names: XIAFLEX®, AA4500

Placebo

Biological

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.

Primary outcomes

  1. Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection

    Time frame: Within 30 days 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.

Secondary outcomes

  1. Clinical Improvement After the Last Injection

    Time frame: Baseline; within 30 days after the last injection

    Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection.

  2. Percent Reduction From Baseline Contracture After the Last Injection

    Time frame: Baseline; within 30 days after the last injection

    Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.

  3. Change From Baseline Range of Motion After the Last Injection

    Time frame: Baselin; within 30 days after the last injection

    Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.

  4. Time to First Achieve Success After the Last Injection

    Time frame: Last evaluation visit on which clinical success is achieved through the Day 30 evaluation

  5. Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection

    Time frame: Within 30 days after first injection

    Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.

  6. Clinical Improvement After the First Injection

    Time frame: Baseline; within 30 days 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.

  7. Percent Reduction From Baseline Contracture After the First Injection

    Time frame: Baseline, within 30 days after the first injection

    Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.

  8. Change From Baseline Range of Motion After the First Injection

    Time frame: Baseline; within 30 days after the first injection

    Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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

Acronym: CORD-I

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2007
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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