Trial · NCT00528606

AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

NCT00528606, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2010-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture. Trials, record NCT00528606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00528606

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Trial

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

Title: AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
NCT number: NCT00528606
Status: Completed
Phases: Phase 3
Enrollment: 308 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Dupuytren's Contracture
Interventions: collagenase clostridium histolyticum, Placebo
First posted: 2007-09-12
Last updated: 2017-12-02
Results first posted: 2010-10-22

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection	Within 30 days after the last injection	The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection. The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Secondary	Clinical Improvement After the Last Injection	Baseline; within 30 days after the last injection	Clinical Improvement is defined as \>= 50% reduction from baseline in degree of contracture within 30 days of the injection.
Secondary	Percent Reduction From Baseline Contracture After the Last Injection	Baseline; within 30 days after the last injection	Percent change in degree of contracture measured as 100\* (baseline contracture - last available post-injection contracture)/baseline contracture.
Secondary	Change From Baseline Range of Motion After the Last Injection	Baselin; within 30 days after the last injection	Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.
Secondary	Time to First Achieve Success After the Last Injection	Last evaluation visit on which clinical success is achieved through the Day 30 evaluation
Secondary	Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection	Within 30 days after first injection	Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.
Secondary	Clinical Improvement After the First Injection	Baseline; within 30 days after the first injection	Clinical Improvement is defined as \>= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.
Secondary	Percent Reduction From Baseline Contracture After the First Injection	Baseline, within 30 days after the first injection	Percent change in degree of contracture measured as 100\* (baseline contracture - last available post-injection contracture)/baseline contracture.
Secondary	Change From Baseline Range of Motion After the First Injection	Baseline; within 30 days after the first injection	Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection	Within 30 days after the last injection	Modified-Intent-to-Treat population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)	Percentage of Joints	NUMBER
SECONDARY	Clinical Improvement After the Last Injection	Baseline; within 30 days after the last injection	Modified ITT population( Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)	Percentage of Joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the Last Injection	Baseline; within 30 days after the last injection	Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)	Percent reduction from baseline	MEAN
SECONDARY	Change From Baseline Range of Motion After the Last Injection	Baselin; within 30 days after the last injection	Modified ITT Population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)	degrees	MEAN
SECONDARY	Time to First Achieve Success After the Last Injection	Last evaluation visit on which clinical success is achieved through the Day 30 evaluation	Modified ITT population	percentage of joints	NUMBER
SECONDARY	Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection	Within 30 days after first injection	Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)	Percentage of Joints	NUMBER
SECONDARY	Clinical Improvement After the First Injection	Baseline; within 30 days after the first injection	Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees)	Percentage of Joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the First Injection	Baseline, within 30 days after the first injection	Modified ITT population	Percent reduction from baseline	MEAN
SECONDARY	Change From Baseline Range of Motion After the First Injection	Baseline; within 30 days after the first injection	Modified ITT population (Change in degree of motion measured as last available post-injection range of motion - baseline range of motion)	degrees	MEAN

Source ClinicalTrials.gov

Results by group42

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

Outcome	Group	Category	Value	Spread	Units
Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection	AA4500 0.58 mg		64		Percentage of Joints
Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection	Placebo		6.8		Percentage of Joints
Clinical Improvement After the Last Injection	AA4500 0.58 mg		84.7		Percentage of Joints
Clinical Improvement After the Last Injection	Placebo		11.7		Percentage of Joints
Percent Reduction From Baseline Contracture After the Last Injection	AA4500 0.58 mg		79.3	Standard Deviation 32.58	Percent reduction from baseline
Percent Reduction From Baseline Contracture After the Last Injection	Placebo		8.6	Standard Deviation 30.78	Percent reduction from baseline
Change From Baseline Range of Motion After the Last Injection	AA4500 0.58 mg		36.70	Standard Deviation 21.01	degrees
Change From Baseline Range of Motion After the Last Injection	Placebo		4.0	Standard Deviation 14.77	degrees
Time to First Achieve Success After the Last Injection	AA4500 0.58 mg	Injection 1, Day 1	12.8		percentage of joints
Time to First Achieve Success After the Last Injection	Placebo	Injection 1, Day 1	0.0		percentage of joints

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AA4500 0.58 mg	204
Overall Study	STARTED	Placebo	104
Overall Study	COMPLETED	AA4500 0.58 mg	191
Overall Study	COMPLETED	Placebo	100
Overall Study	NOT COMPLETED	AA4500 0.58 mg	13
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events48

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	Events
other	Blister	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	11	204	13
other	Blister	Skin and subcutaneous tissue disorders	Placebo	0	104	0
other	Contusion	Injury, poisoning and procedural complications	AA4500 0.58 mg	104	204	178
other	Contusion	Injury, poisoning and procedural complications	Placebo	2	104	2
other	Ecchymosis	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	51	204	72
other	Ecchymosis	Skin and subcutaneous tissue disorders	Placebo	1	104	1
other	Erythema	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	13	204	16
other	Erythema	Skin and subcutaneous tissue disorders	Placebo	0	104	0
other	Injection site haemorrhage	General disorders	AA4500 0.58 mg	76	204	142
other	Injection site haemorrhage	General disorders	Placebo	4	104	4

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AA4500 0.58 mg
Total, all-cause mortality	Placebo
Total, other adverse events	AA4500 0.58 mg	196	204
Total, other adverse events	Placebo	25	104
Total, serious adverse events	AA4500 0.58 mg	8	204
Total, serious adverse events	Placebo	1	104

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19726771	DERIVED	PubMed
21967070	DERIVED	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 0.58 mg 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/NCT00528606

GET https://conductscience.org/api/trials/v1/NCT00528606/results?page=2

API reference For AI assistants