Trial · NCT01588353

Collagenase Option for Reduction of Dupuytren's Contracture in Japan

NCT01588353, Phase 3, Completed, Asahi Kasei Therapeutics Corporation; results first posted 2017-02-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Collagenase Option for Reduction of Dupuytren's Contracture in Japan. Trials, record NCT01588353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01588353

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Collagenase Option for Reduction of Dupuytren's Contracture in Japan
NCT number: NCT01588353
Status: Completed
Phases: Phase 3
Enrollment: 104 participants, actual
Lead sponsor: Asahi Kasei Therapeutics Corporation
Conditions: Dupuytren's Contracture
Interventions: Collagenase Clostridium Histolyticum
First posted: 2012-04-30
Last updated: 2017-03-21
Results first posted: 2017-02-14

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"	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.
Secondary	Clinical Improvement After the Last Injection	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.
Secondary	Percent Reduction From Baseline Contracture After the Last Injection	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.
Secondary	Change From Baseline Range of Motion After the Last Injection	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.
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 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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Percentage of Participants That Were Successfully Treated With a Successful Reduction in Contracture to 5°or Less	30 days after the last injection	The primary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.	% Participants	NUMBER
SECONDARY	Clinical Improvement After the Last Injection	30 days after the last injection	The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.	% Participants	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the Last Injection	30 days after last treatment	The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.	% of change from baseline	MEAN
SECONDARY	Change From Baseline Range of Motion After the Last Injection	30 days after last treatment	The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.	Degrees	MEAN
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 of each injections, assessed up to 3 months	The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.	Days	MEDIAN

Source ClinicalTrials.gov

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Percentage of Participants That Were Successfully Treated With a Successful Reduction in Contracture to 5°or Less	AK160 0.58 mg Step 1-2	86		% Participants
Clinical Improvement After the Last Injection	Primary MP Joints	100	95% Confidence Interval 92.5 to 100.0	% Participants
Clinical Improvement After the Last Injection	Primary PIP Joints	90.0	95% Confidence Interval 73.5 to 97.9	% Participants
Clinical Improvement After the Last Injection	Total	96.1	95% Confidence Interval 89.0 to 99.2	% Participants
Percent Reduction From Baseline Contracture After the Last Injection	Primary MP Joints	97.08	Standard Deviation 7.791	% of change from baseline
Percent Reduction From Baseline Contracture After the Last Injection	Primary PIP Joints	82.48	Standard Deviation 24.674	% of change from baseline
Percent Reduction From Baseline Contracture After the Last Injection	Total	91.39	Standard Deviation 17.900	% of change from baseline
Change From Baseline Range of Motion After the Last Injection	Primary MP Joints	41.6	Standard Deviation 18.91	Degrees
Change From Baseline Range of Motion After the Last Injection	Primary PIP Joints	33.3	Standard Deviation 17.73	Degrees
Change From Baseline Range of Motion After the Last Injection	Total	38.4	Standard Deviation 18.79	Degrees

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Step1	STARTED	AK160 0.58 mg Step1	6
Step1	STARTED	AK160 0.58 mg Step 2	0
Step1	STARTED	AK160 0.58 mg Step3	0
Step1	COMPLETED	AK160 0.58 mg Step1	6
Step1	COMPLETED	AK160 0.58 mg Step 2	0
Step1	COMPLETED	AK160 0.58 mg Step3	0
Step1	NOT COMPLETED	AK160 0.58 mg Step1	0
Step1	NOT COMPLETED	AK160 0.58 mg Step 2	0
Step1	NOT COMPLETED	AK160 0.58 mg Step3	0
Step2	STARTED	AK160 0.58 mg Step1	0

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Injection site pain	General disorders	AK160 0.58 mg Step 1-3	78	102
other	Injection site bruising	General disorders	AK160 0.58 mg Step 1-3	46	102
other	Injection site swelling	General disorders	AK160 0.58 mg Step 1-3	35	102
other	Contusion	Injury, poisoning and procedural complications	AK160 0.58 mg Step 1-3	30	102
other	Injection site laceration	General disorders	AK160 0.58 mg Step 1-3	16	102
other	Nasopharyngitis	Infections and infestations	AK160 0.58 mg Step 1-3	16	102
other	Injection site oedema	General disorders	AK160 0.58 mg Step 1-3	12	102
other	Injection site haematoma	General disorders	AK160 0.58 mg Step 1-3	11	102
other	Local swelling	General disorders	AK160 0.58 mg Step 1-3	9	102
other	Laceration	Injury, poisoning and procedural complications	AK160 0.58 mg Step 1-3	9	102

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AK160 0.58 mg Step 1-3
Total, other adverse events	AK160 0.58 mg Step 1-3	100	102
Total, serious adverse events	AK160 0.58 mg Step 1-3	14	102

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27313184	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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