Trial · NCT00528840

Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

NCT00528840, 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. Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease. Trials, record NCT00528840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00528840

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Trial

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

Title: Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
NCT number: NCT00528840
Status: Completed
Phases: Phase 3
Enrollment: 201 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Advanced Dupuytren's Disease
Interventions: collagenase clostridium histolyticum
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	Reduction in Contracture to 5° or Less	Within 30 days after the last injection	The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection
Secondary	Clinical Improvement After the Last Injection	Baseline; within 30 days after last injection	Clinical Improvement is defined as \>=50% percent reduction from baseline in degree of contracture within 30 days after injection.
Secondary	Percent Reduction From Baseline Contracture After the Last Injection	Baseline, within 30 days after 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	Baseline, 30 days after last injection	Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.
Secondary	Time to Reach Clinical Success	First evaluation visit on which clinical success is achieved through the Day 30 evaluation	Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.
Secondary	Clinical Success 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 first injection	Clinical Improvement is defined as \>=50% reduction from baseline in the degree of contracture within 30 days after the first injection
Secondary	Percent Reduction From Baseline Contracture After the First Injection	Baseline; within 30 days after first injection	Percent change in degree of contracture is 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 first injection	Change in degree of range 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	Reduction in Contracture to 5° or Less	Within 30 days after the last injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	percentage of joints	NUMBER
SECONDARY	Clinical Improvement After the Last Injection	Baseline; within 30 days after last injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	percent of joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the Last Injection	Baseline, within 30 days after last injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	percentage of joints	MEAN
SECONDARY	Change From Baseline Range of Motion After the Last Injection	Baseline, 30 days after last injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	degrees	MEAN
SECONDARY	Time to Reach Clinical Success	First evaluation visit on which clinical success is achieved through the Day 30 evaluation	Intent to treat population (ITT) defined as all subjects who received at least one injection.	percentage of joints	NUMBER
SECONDARY	Clinical Success After the First Injection	Within 30 days after first injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	percentage of joints	NUMBER
SECONDARY	Clinical Improvement After the First Injection	Baseline; within 30 days after first injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	percentage of joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the First Injection	Baseline; within 30 days after first injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	percentage of change	MEAN
SECONDARY	Change From Baseline Range of Motion After the First Injection	Baseline; within 30 days after first injection	Intent to treat population (ITT) defined as all subjects who received at least one injection.	degrees	MEAN

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Reduction in Contracture to 5° or Less	AA4500 0.58 mg		52.7		percentage of joints
Clinical Improvement After the Last Injection	AA4500 0.58 mg		71.6		percent of joints
Percent Reduction From Baseline Contracture After the Last Injection	AA4500 0.58 mg		66.8	Standard Deviation 40.91	percentage of joints
Change From Baseline Range of Motion After the Last Injection	AA4500 0.58 mg		28.3	Standard Deviation 20.15	degrees
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 1, Day 1	9.6		percentage of joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 1, Day 7	16.4		percentage of joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 1, Day 30	16.1		percentage of joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 2, Day 0	0.0		percentage of joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 2, Day 1	2.4		percentage of joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 2, Day 7	2.4		percentage of joints

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AA4500 0.58 mg	201
Overall Study	COMPLETED	AA4500 0.58 mg	168
Overall Study	NOT COMPLETED	AA4500 0.58 mg	33

Source ClinicalTrials.gov

Adverse events38

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	Arthralgia	Musculoskeletal and connective tissue disorders	AA4500 0.58 mg	10	201	10
other	Blood blister	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	10	201	11
other	Contusion	Injury, poisoning and procedural complications	AA4500 0.58 mg	100	201	174
other	Ecchymosis	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	43	201	98
other	Erythema	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	12	201	15
other	Haematoma	Vascular disorders	AA4500 0.58 mg	12	201	13
other	Injection site haemorrhage	General disorders	AA4500 0.58 mg	109	201	168
other	Injection site pain	General disorders	AA4500 0.58 mg	116	201	182
other	Injection site pruritus	General disorders	AA4500 0.58 mg	19	201	23
other	Injection site swelling	General disorders	AA4500 0.58 mg	57	201	98

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AA4500 0.58 mg
Total, other adverse events	AA4500 0.58 mg	197	201
Total, serious adverse events	AA4500 0.58 mg	11	201

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

For software

Read this trial from software.

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