Trial · NCT00528424

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

NCT00528424, 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 Advanced Dupuytren's Disease. Trials, record NCT00528424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00528424

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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 Advanced Dupuytren's Disease
NCT number: NCT00528424
Status: Completed
Phases: Phase 3
Enrollment: 286 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Advanced Dupuytren's Disease
Interventions: AA4500
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 last injection	Successfully treated or clinical success in non-primary joints 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 last injection	Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Secondary	Percent Reduction From Baseline Contracture After the Last Injection	Baseline, Day 30 after last injection	Percent change in degree of contracture in non-primary joints measured as 100 \* (baseline contracture - last available post-injection contracture)/baseline contracture.
Secondary	Change From Baseline Range of Motion After the Last Injection	Baseline, Day 30 after last injection	Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
Secondary	Time to Reach Clinical Success	Within 30 days after last injection	Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
Secondary	Clinical Success After the First Injection	Within 30 days after first injection	Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Secondary	Clinical Improvement After the First Injection	Baseline, within 30 days after first injection	Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Secondary	Percent Reduction From Baseline Contracture After the First Injection	Baseline, Day 30 after first injection	Percent change in degree of contracture in non-primary joints measured as 100 \* (baseline contracture - last available post-injection contracture)/baseline contracture.
Secondary	Change From Baseline Range of Motion After the First Injection	Baseline, Day 30 after first injection	Change in degree of range of motion in non-primary joints 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 last injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Percentage of joints	NUMBER
SECONDARY	Clinical Improvement After the Last Injection	Baseline, within 30 days after last injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Percentage of joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the Last Injection	Baseline, Day 30 after last injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Percentage of change	MEAN
SECONDARY	Change From Baseline Range of Motion After the Last Injection	Baseline, Day 30 after last injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Degrees	MEAN
SECONDARY	Time to Reach Clinical Success	Within 30 days after last injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Percentage of Joints	NUMBER
SECONDARY	Clinical Success After the First Injection	Within 30 days after first injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Percentage of Joints	NUMBER
SECONDARY	Clinical Improvement After the First Injection	Baseline, within 30 days after first injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Percentage of Joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture After the First Injection	Baseline, Day 30 after first injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Percentage of change	MEAN
SECONDARY	Change From Baseline Range of Motion After the First Injection	Baseline, Day 30 after first injection	Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants.	Degrees	MEAN

Source ClinicalTrials.gov

Results by group20

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		41.9		Percentage of joints
Clinical Improvement After the Last Injection	AA4500 0.58 mg		65.0		Percentage of joints
Percent Reduction From Baseline Contracture After the Last Injection	AA4500 0.58 mg		60.8	Standard Deviation 39.00	Percentage of change
Change From Baseline Range of Motion After the Last Injection	AA4500 0.58 mg		24.0	Standard Deviation 20.83	Degrees
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 1, Day 1	12.5		Percentage of Joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 1, Day 7	15.9		Percentage of Joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 1, Day 30	5.9		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	2.2		Percentage of Joints
Time to Reach Clinical Success	AA4500 0.58 mg	Injection 2, Day 7	1.3		Percentage of Joints

1 to 10 of 20Source ClinicalTrials.gov

See all 20 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	286
Overall Study	COMPLETED	AA4500 0.58 mg	257
Overall Study	NOT COMPLETED	AA4500 0.58 mg	29

Source ClinicalTrials.gov

Adverse events25

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	Blood blister	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	21	286	22
other	Contusion	Injury, poisoning and procedural complications	AA4500 0.58 mg	95	286	205
other	Dupuytren's contracture	Musculoskeletal and connective tissue disorders	AA4500 0.58 mg	15	286	15
other	Ecchymosis	Skin and subcutaneous tissue disorders	AA4500 0.58 mg	39	286	67
other	Injection site haemorrhage	General disorders	AA4500 0.58 mg	52	286	95
other	Injection site pain	General disorders	AA4500 0.58 mg	47	286	74
other	Injection site pruritus	General disorders	AA4500 0.58 mg	15	286	26
other	Injection site swelling	General disorders	AA4500 0.58 mg	34	286	56
other	Oedema peripheral	General disorders	AA4500 0.58 mg	136	286	386
other	Pain	General disorders	AA4500 0.58 mg	15	286	27

1 to 10 of 25Source ClinicalTrials.gov

See all 25 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	171	286
Total, serious adverse events	AA4500 0.58 mg	9	286

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.

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

GET https://conductscience.org/api/trials/v1/NCT00528424

GET https://conductscience.org/api/trials/v1/NCT00528424/events?page=2

API reference For AI assistants