Clinical Trial: Collagenase Option for Reduction of Dupuytren's Contracture in Japan

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Asahi Kasei Pharma Corporation

Current Primary Outcome: 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.


Original Primary Outcome: The percentage of patients that were successfully treated with a "successful reduction in contracture to 5°or less" [ Time Frame: 30 days after the last injection ]

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Clinical Improvement After the Last Injection [ Time Frame: 30 days after the last injection ]
  • Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: 30 days after last treatment ]
  • Change From Baseline Range of Motion After the Last Injection [ Time Frame: 30 days after last treatment ]
  • 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 ]


Information By: Asahi Kasei Pharma Corporation

Dates:
Date Received: April 27, 2012
Date Started: May 2012
Date Completion:
Last Updated: February 14, 2017
Last Verified: February 2017