Clinical trial NCT01588353: Collagenase Option for Reduction of Dupuytren's Contracture in Japan
Official title: Phase III Study of AK160 in Patients With Dupuytren's Contracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dupuytren's Contracture
Keywords: AK160, collagenase clostridium histolyticum
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
timeFrame: 30 days after the last injection
Secondary outcomes:
measure: Clinical Improvement After the Last Injection
timeFrame: 30 days after the last injection
measure: Percent Reduction From Baseline Contracture After the Last Injection
timeFrame: 30 days after last treatment
measure: Change From Baseline Range of Motion After the Last Injection
timeFrame: 30 days after last treatment
measure: Time to First Achieve and Maintain Clinical Success After the Last Injection
timeFrame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months
Other outcomes:
Locations:
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
Study officials:
References:
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.