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

Primary Purpose

Dupuytren's Contracture

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Collagenase Clostridium Histolyticum
Sponsored by
Asahi Kasei Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren's Contracture focused on measuring AK160, collagenase clostridium histolyticum

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AK160 0.58 mg

Arm Description

Outcomes

Primary Outcome Measures

The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
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
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
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
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
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.

Full Information

First Posted
April 27, 2012
Last Updated
February 14, 2017
Sponsor
Asahi Kasei Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01588353
Brief Title
Collagenase Option for Reduction of Dupuytren's Contracture in Japan
Acronym
CORD-J
Official Title
Phase III Study of AK160 in Patients With Dupuytren's Contracture
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Contracture
Keywords
AK160, collagenase clostridium histolyticum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AK160 0.58 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Collagenase Clostridium Histolyticum
Other Intervention Name(s)
Xiaflex® (US), Xiapex® (EU)
Intervention Description
AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
Primary Outcome Measure Information:
Title
The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
Description
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.
Time Frame
30 days after the last injection
Secondary Outcome Measure Information:
Title
Clinical Improvement After the Last Injection
Description
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.
Time Frame
30 days after the last injection
Title
Percent Reduction From Baseline Contracture After the Last Injection
Description
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.
Time Frame
30 days after last treatment
Title
Change From Baseline Range of Motion After the Last Injection
Description
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 Frame
30 days after last treatment
Title
Time to First Achieve and Maintain Clinical Success After the Last Injection
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Aichi
Country
Japan
City
Aomori
Country
Japan
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Hiroshima
Country
Japan
City
Hokkaido
Country
Japan
City
Ishikawa
Country
Japan
City
Iwate
Country
Japan
City
Kanagawa
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Mie
Country
Japan
City
Nagano
Country
Japan
City
Nagasaki
Country
Japan
City
Niigata
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo
Country
Japan
City
Yamaguchi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27313184
Citation
Hirata H, Tanaka K, Sakai A, Kakinoki R, Ikegami H, Tateishi N. Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population. J Hand Surg Eur Vol. 2017 Jan;42(1):30-38. doi: 10.1177/1753193416653249. Epub 2016 Sep 28.
Results Reference
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Collagenase Option for Reduction of Dupuytren's Contracture in Japan

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