Trial · NCT00528931

A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

NCT00528931, Phase 1, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2012-08-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture. Trials, record NCT00528931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00528931

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Trial

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

Title: A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
NCT number: NCT00528931
Status: Completed
Phases: Phase 1
Enrollment: 16 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Dupuytren's Contracture
Interventions: collagenase clostridium histolyticum
First posted: 2007-09-12
Last updated: 2017-10-05
Results first posted: 2012-08-20

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500	Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30	AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).
Secondary	Clinical Success	30 days after treatment to the primary joint	Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.
Secondary	Clinical Improvement	30 days after treatment to the primary joint	Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined.
Secondary	Percent Change From Baseline Contracture	Baseline, 30 days after treatment to the primary joint	Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture.
Secondary	Change From Baseline Range of Motion	Baseline, 30 days after treatment to the primary joint	Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500	Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30	Pharmacokinetic population	participants	NUMBER
SECONDARY	Clinical Success	30 days after treatment to the primary joint	Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection	Percentage of joints	NUMBER
SECONDARY	Clinical Improvement	30 days after treatment to the primary joint	Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.	Percentage of joints	NUMBER
SECONDARY	Percent Change From Baseline Contracture	Baseline, 30 days after treatment to the primary joint	Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.	Percentage of contracture change	MEAN
SECONDARY	Change From Baseline Range of Motion	Baseline, 30 days after treatment to the primary joint	Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.	Degrees	MEAN

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500	AA4500 0.58 mg	0		participants
Clinical Success	AA4500 0.58 mg	75.0		Percentage of joints
Clinical Improvement	AA4500 0.58 mg	100.0		Percentage of joints
Percent Change From Baseline Contracture	AA4500 0.58 mg	91.6	Standard Deviation 16.57	Percentage of contracture change
Change From Baseline Range of Motion	AA4500 0.58 mg	39.1	Standard Deviation 15.38	Degrees

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AA4500 0.58 mg	16
Overall Study	COMPLETED	AA4500 0.58 mg	15
Overall Study	NOT COMPLETED	AA4500 0.58 mg	1

Source ClinicalTrials.gov

Adverse events17

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	1	16	1
other	Blood urine present	Investigations	AA4500 0.58 mg	1	16	1
other	Burning sensation	Nervous system disorders	AA4500 0.58 mg	1	16	1
other	Contusion	Injury, poisoning and procedural complications	AA4500 0.58 mg	1	16	1
other	Food poisoning	Gastrointestinal disorders	AA4500 0.58 mg	1	16	1
other	Hypertension	Vascular disorders	AA4500 0.58 mg	2	16	2
other	Injection site haemorrhage	General disorders	AA4500 0.58 mg	15	16	15
other	Injection site oedema	General disorders	AA4500 0.58 mg	1	16	1
other	Injection site pain	General disorders	AA4500 0.58 mg	13	16	13
other	Injection site swelling	General disorders	AA4500 0.58 mg	14	16	14

1 to 10 of 17Source ClinicalTrials.gov

See all 17 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	16	16
Total, serious adverse events	AA4500 0.58 mg	1	16

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/NCT00528931

GET https://conductscience.org/api/trials/v1/NCT00528931/registered

API reference For AI assistants