Trial · NCT00533273

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

NCT00533273, 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. Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease. Trials, record NCT00533273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00533273

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Trial

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

Title: Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
NCT number: NCT00533273
Status: Completed
Phases: Phase 3
Enrollment: 66 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Advanced Dupuytren's Disease
Interventions: collagenase clostridium histolyticum
First posted: 2007-09-21
Last updated: 2017-12-02
Results first posted: 2010-10-22

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Reduction in Primary Joint Contracture to 5° or Less	Within 30 days after last injection	Successfully treated or clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Secondary	Clinical Improvement in Primary Joint After the Last Injection	Baseline, Within 30 days after last injection	Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Secondary	Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection	Baseline, Day 30 after last injection	Percent change in degree of contracture of primary joint measured as 100 \* (baseline contracture - last available post-injection contracture)/baseline contracture
Secondary	Change From Baseline Range of Motion in Primary Joint After the Last Injection	Baseline, Day 30 after last injection	Change in degree of range of motion in primary joint measured as last available post-injection range of motion - baseline range of motion
Secondary	Time to Reach Clinical Success in Primary Joint	Within 30 days after last injection	Clinical success in primary joint 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 in Primary Joint After the First Injection	Within 30 days after first injection	Clinical success in primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Secondary	Clinical Improvement in Primary Joint After the First Injection	Baseline, Within 30 days after first injection	Clinical improvement in primary joint defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Secondary	Percent Reduction From Baseline Contracture of Primary Joint After the First Injection	Baseline, Day 30 after first injection	Percent change in degree of contracture of primary joint measured as 100 \* (baseline contracture - last available post-injection contracture prior to next injection)/baseline contracture
Secondary	Change From Baseline Range of Motion in Primary Joint After the First Injection	Baseline, Day 30 after first injection	Change in degree of range of motion in primary joint measured as last available post-injection range of motion prior to the next injection - baseline range of motion
Secondary	Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection	Within 30 days after last injection	Successfully treated or clinical success in non-primary joint defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Reduction in Primary Joint Contracture to 5° or Less	Within 30 days after last injection	Subjects who were randomized and received at least 1 injection	Percentage of Joints	NUMBER
SECONDARY	Clinical Improvement in Primary Joint After the Last Injection	Baseline, Within 30 days after last injection	Subjects who were randomized and received at least 1 injection	Percentage of Joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection	Baseline, Day 30 after last injection	Subjects who were randomized and received at least 1 injection	Percentage of change	MEAN
SECONDARY	Change From Baseline Range of Motion in Primary Joint After the Last Injection	Baseline, Day 30 after last injection	Subjects who were randomized and received at least 1 injection	Degrees	MEAN
SECONDARY	Time to Reach Clinical Success in Primary Joint	Within 30 days after last injection	Subjects who were randomized and received at least 1 injection	Percentage of Joints	NUMBER
SECONDARY	Clinical Success in Primary Joint After the First Injection	Within 30 days after first injection	Subjects who were randomized and received at least 1 injection	Percentage of Joints	NUMBER
SECONDARY	Clinical Improvement in Primary Joint After the First Injection	Baseline, Within 30 days after first injection	Subjects who were randomized and received at least 1 injection	Percentage of Joints	NUMBER
SECONDARY	Percent Reduction From Baseline Contracture of Primary Joint After the First Injection	Baseline, Day 30 after first injection	Subjects who were randomized and received at least 1 injection	Percentage of change	MEAN
SECONDARY	Change From Baseline Range of Motion in Primary Joint After the First Injection	Baseline, Day 30 after first injection	Subjects who were randomized and received at least 1 injection	Degrees	MEAN
SECONDARY	Reduction in Non-primary Joint Contracture to 5° or Less After the Last Injection	Within 30 days after last injection	Includes evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture \>5° and at least 1 post-injection contracture measurement in subjects who received at least 1 non-primary joint injection in either study period	Percentage of Joints	NUMBER

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group56

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

Outcome	Group	Category	Value	Spread	Units
Reduction in Primary Joint Contracture to 5° or Less	AA4500 0.58 mg		44.4		Percentage of Joints
Reduction in Primary Joint Contracture to 5° or Less	Placebo		4.8		Percentage of Joints
Clinical Improvement in Primary Joint After the Last Injection	AA4500 0.58 mg		77.8		Percentage of Joints
Clinical Improvement in Primary Joint After the Last Injection	Placebo		14.3		Percentage of Joints
Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection	AA4500 0.58 mg		70.5	Standard Deviation 29.21	Percentage of change
Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection	Placebo		13.6	Standard Deviation 26.10	Percentage of change
Change From Baseline Range of Motion in Primary Joint After the Last Injection	AA4500 0.58 mg		35.4	Standard Deviation 17.77	Degrees
Change From Baseline Range of Motion in Primary Joint After the Last Injection	Placebo		7.6	Standard Deviation 14.88	Degrees
Time to Reach Clinical Success in Primary Joint	AA4500 0.58 mg	Injection 1, Day 1	2.2		Percentage of Joints
Time to Reach Clinical Success in Primary Joint	Placebo	Injection 1, Day 1	0.0		Percentage of Joints

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Double-blind	STARTED	AA4500 0.58 mg	45
Double-blind	STARTED	Placebo	21
Double-blind	COMPLETED	AA4500 0.58 mg	45
Double-blind	COMPLETED	Placebo	19
Double-blind	NOT COMPLETED	AA4500 0.58 mg	0
Double-blind	NOT COMPLETED	Placebo	2
Open-label	STARTED	AA4500 0.58 mg	64
Open-label	STARTED	Placebo	0
Open-label	COMPLETED	AA4500 0.58 mg	58
Open-label	COMPLETED	Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events56

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	Axillary pain	Musculoskeletal and connective tissue disorders	AA4500 0.58 mg	8	63	11
other	Axillary pain	Musculoskeletal and connective tissue disorders	Placebo	0	21	0
other	Contusion	Injury, poisoning and procedural complications	AA4500 0.58 mg	46	63	136
other	Contusion	Injury, poisoning and procedural complications	Placebo	2	21	4
other	Dizziness	Nervous system disorders	AA4500 0.58 mg	5	63	5
other	Dizziness	Nervous system disorders	Placebo	0	21	0
other	Haematuria	Renal and urinary disorders	AA4500 0.58 mg	2	63	2
other	Haematuria	Renal and urinary disorders	Placebo	2	21	2
other	Headache	Nervous system disorders	AA4500 0.58 mg	2	63	2
other	Headache	Nervous system disorders	Placebo	2	21	3

1 to 10 of 56Source ClinicalTrials.gov

See all 56 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	63	63
Total, other adverse events	Placebo	10	21
Total, serious adverse events	AA4500 0.58 mg	7	63
Total, serious adverse events	Placebo	1	21

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 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/NCT00533273

GET https://conductscience.org/api/trials/v1/NCT00533273/results?page=2

API reference For AI assistants