Collagenase Option for Reduction of Dupuytren's Contracture in Japan

Dupuytren's Contracture Clinical Trial

— CORD-J  

Official title:

Phase III Study of AK160 in Patients With Dupuytren's Contracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588353
• Other study ID #: AK160-III-1
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2012
• Last updated: June 30, 2014
• Start date: May 2012
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Contracture

Intervention

Drug:
• Collagenase Clostridium Histolyticum
AK160 (Collagenase Clostridium Histolyticum) 0.58 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients that were successfully treated with a "successful reduction in contracture to 5°or less"		30 days after the last injection	No
Secondary	Clinical Improvement After the Last Injection		30 days after the last injection	No
Secondary	Percent Reduction From Baseline Contracture After the Last Injection		30 days after last treatment	No
Secondary	Change From Baseline Range of Motion After the Last Injection		30 days after last treatment	No
Secondary	Time to First Achieve and Maintain Clinical Success After the Last Injection		First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation	No