Trial · NCT00260429

Collagenase in the Treatment of Dupuytrens Disease

NCT00260429, Phase 3, Completed, Stony Brook University; results first posted 2010-12-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Collagenase in the Treatment of Dupuytrens Disease. Trials, record NCT00260429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00260429

On this page

Trial

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

Title: Collagenase in the Treatment of Dupuytrens Disease
NCT number: NCT00260429
Status: Completed
Phases: Phase 3
Enrollment: 38 participants, actual
Lead sponsor: Stony Brook University
Conditions: Dupuytren's Disease
Interventions: collagenase clostridium histolyticum
First posted: 2005-12-01
Last updated: 2010-12-09
Results first posted: 2010-12-09

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.	30 days after the last injection	The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less. The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
Secondary	Percent Reduction From Baseline Contracture After the Last Injection	30 days after last treatment to the primary joint
Secondary	Percent Change From Baseline Range of Motion After the Last Injection	30 days after last treatment to the primary joint
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 the primary joint
Secondary	Clinical Success After the First Injection	30 days after first treatment to the primary joint
Secondary	Percent Reduction From Baseline Contracture After the First Injection	30 days after first treatment to the primary joint
Secondary	Change From Baseline Range of Motion After the First Injection	30 days after first treatment to the primary joint

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.	30 days after the last injection	% Joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the Last Injection	30 days after last treatment to the primary joint	Joints	MEAN
SECONDARY	Percent Change From Baseline Range of Motion After the Last Injection	30 days after last treatment to the primary joint	Joints	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 the primary joint	Joints	NUMBER
SECONDARY	Clinical Success After the First Injection	30 days after first treatment to the primary joint	Joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the First Injection	30 days after first treatment to the primary joint	Joints	MEAN
SECONDARY	Change From Baseline Range of Motion After the First Injection	30 days after first treatment to the primary joint	Joints	MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.	AA4500		91.3		% Joints
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.	Placebo		0		% Joints

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AA4500	23
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	AA4500	21
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	AA4500	2
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events34

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	Edema peripheral	General disorders	AA4500	23	23
other	Edema peripheral	General disorders	Placebo	1	15
other	Injection site pain	General disorders	AA4500	23	23
other	Injection site pain	General disorders	Placebo	7	15
other	Ecchymosis	Skin and subcutaneous tissue disorders	AA4500	12	23
other	Ecchymosis	Skin and subcutaneous tissue disorders	Placebo	0	15
other	Blood blister	Skin and subcutaneous tissue disorders	AA4500	10	23
other	Blood blister	Skin and subcutaneous tissue disorders	Placebo	0	15
other	Lymphadenopathy	Blood and lymphatic system disorders	AA4500	10	23
other	Lymphadenopathy	Blood and lymphatic system disorders	Placebo	0	15

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AA4500
Total, all-cause mortality	Placebo
Total, other adverse events	AA4500	23	23
Total, other adverse events	Placebo	12	15
Total, serious adverse events	AA4500	2	23
Total, serious adverse events	Placebo	1	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
12239666	BACKGROUND

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 comparisons1

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

Comparison
AA4500 vs Placebo: serious adverse events

Source Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00260429

GET https://conductscience.org/api/trials/v1/NCT00260429/events?page=2

API reference For AI assistants