Loading clinical trials...

Collagenase Option for Reduction of Dupuytren's Contracture in Japan | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

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

NCT01588353•Asahi Kasei Pharma Corporation

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

Age

20 - No limit years

Sex

ALL

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.
+5 more criteria

Locations (20)

Aichi, Japan

Aomori, Japan

Chiba, Japan

Fukuoka, Japan

Hiroshima, Japan

Hokkaido, Japan

Ishikawa, Japan

Kanagawa, Japan

Kumamoto, Japan

Kyoto, Japan

Key Dates

Start Date

May 1, 2012

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

March 21, 2017

Enrollment

104

ACTUAL participants

Conditions

Dupuytren's Contracture

Interventions

Collagenase Clostridium Histolyticum

DRUG

Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture

NCT05877066

Dupuytren's Contracture

View study

COMPLETED

Ultrasound B Mode Imaging and Elastography

NCT04607187

Dupuytren's Contractures

View study

COMPLETEDPHASE4

Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

NCT01265420

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

Inclusion Criteria

Exclusion Criteria

Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture

Ultrasound B Mode Imaging and Elastography

Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease

Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)