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Collagenase Option for Reduction of Dupuytren's Contracture in Japan (CORD-J)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01588353
First received: April 27, 2012
Last updated: December 21, 2016
Last verified: December 2016
  Purpose

To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.

To determine plasma concentration after the first injection of AK160 in patients with Dupuytren's Contracture.


Condition Intervention Phase
Dupuytren's Contracture
Drug: Collagenase Clostridium Histolyticum
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of AK160 in Patients With Dupuytren's Contracture

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Pharma Corporation:

Primary Outcome Measures:
  • The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less" [ Time Frame: 30 days after the last injection ]
    The Primary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were successfully treated where "successfully treated" was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times.


Secondary Outcome Measures:
  • Clinical Improvement After the Last Injection [ Time Frame: 30 days after the last injection ]
    The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were clinically improved where "clinically improved" was defined as reduction in the contracture of the first treated joint by 50% or more from the baseline. The injection was allowed up to 3 times.

  • Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: 30 days after last treatment ]
    The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the mean percent decrease from baseline degree of contracture in primary joints after the last injection. The injection was allowed up to 3 times.

  • Change From Baseline Range of Motion After the Last Injection [ Time Frame: 30 days after last treatment ]
    The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the change from baseline range of motion in primary joints after the last injection. The injection was allowed up to 3 times.

  • 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 each injections, assessed up to 3 months ]
    The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the time to first achieve and maintain clinical success after the last injection where "clinical success" was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times.


Enrollment: 104
Study Start Date: May 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AK160 0.58 mg Drug: Collagenase Clostridium Histolyticum
AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
Other Names:
  • Xiaflex® (US)
  • Xiapex® (EU)

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 20 years old when written informed consent is obtained.
  • Having a diagnosis of Dupuytren's contracture and flexion contracture due to palpable cord in at least 1 non-thumb finger (20° to 100° in MP joint and 20° to 80° in PIP joint).
  • Positive tabletop test result (i.e., cannot simultaneously place affected finger and palm on a table).
  • Voluntary written informed consent is obtained.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

  • Is pregnant, may be pregnant, wishes to become or could become pregnant during the study (i.e., unless acceptable contraception is used, the patient has been sterilized, or the patient is postmenopausal [no menstrual period for at least 12 months without any other medical cause]), or is breastfeeding.
  • Has a coexisting chronic disease of the hand that could impact assessment (muscular disease, neurological disease, neuromuscular disease).
  • Has received another investigational product 30 or fewer days before first injection of the investigational product.
  • Has undergone aponeurectomy, aponeurotomy, needle aponeurotomy/fasciotomy, verapamil/interferon injection, or another Dupuytren's Contracture treatment of the primary joint 90 or fewer days before first injection of the investigational product.
  • Is allergic to collagenase or any of the excipients of AK160.
  • Has taken tetracycline derivative such as minocycline and doxycycline 14 or fewer days before first injection of the investigational product.
  • Has received a collagenase product 30 or fewer days before first injection of the investigational product.
  • Is currently taking or has taken, 7 or fewer days before first injection of the investigational product, an anticoagulant or antiplatelet drug (other than ≤150 mg/day of aspirin).
  • Has suffered a recent stroke, hemorrhage, or other disease affecting the hands.
  • Has a serious disease unsuited for the study.
  • Receiving treatment for a malignancy.
  • History of drug or alcohol addiction within the past 5 years or history of drug or alcohol abuse within the past year.
  • Has received previously the investigational product (AK160, AA4500, XIAFLEX®, or XIAPEX®).
  • Otherwise found ineligible as a subject by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588353

Locations
Japan
Aichi, Japan
Aomori, Japan
Chiba, Japan
Fukuoka, Japan
Hiroshima, Japan
Hokkaido, Japan
Ishikawa, Japan
Iwate, Japan
Kanagawa, Japan
Kumamoto, Japan
Kyoto, Japan
Mie, Japan
Nagano, Japan
Nagasaki, Japan
Niigata, Japan
Okayama, Japan
Osaka, Japan
Tokushima, Japan
Tokyo, Japan
Yamaguchi, Japan
Sponsors and Collaborators
Asahi Kasei Pharma Corporation
  More Information

Publications:
Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT01588353     History of Changes
Other Study ID Numbers: AK160-III-1 
Study First Received: April 27, 2012
Results First Received: July 3, 2016
Last Updated: December 21, 2016

Keywords provided by Asahi Kasei Pharma Corporation:
AK160, collagenase clostridium histolyticum

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 20, 2017