Trial · NCT02193828

Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules

NCT02193828, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2015-07-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules. Trials, record NCT02193828. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02193828

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Trial

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

Title: Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules
NCT number: NCT02193828
Status: Completed
Phases: Phase 2
Enrollment: 76 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Dupuytren's Disease
Interventions: Collagenase clostridium histolyticum, Placebo
First posted: 2014-07-18
Last updated: 2017-10-05
Results first posted: 2015-07-07

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	Baseline, Day 57	Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.
Secondary	Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound	Baseline, Day 57	Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.
Secondary	Change From Baseline in Consistency of the Treated Nodules at Day 57	Baseline, Day 57	Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening.
Secondary	Percent Change From Baseline in Hardness of the Treated Nodule at Day 57	Baseline, Day 57	A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100\*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening.
Secondary	Change From Baseline in Nodular Pain of the Treated Nodule at Day 57	Baseline, Day 57	After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening.
Secondary	Investigator Global Assessment of Improvement With Treatment	Day 57	Investigators were asked to determine the degree of improvement in the subject's treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Secondary	Subject Satisfaction With Treatment	Day 57	Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied.
Secondary	Composite Responder Analysis	Day 57	A composite responder is a subject who had an improved assessment \[values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)\] on the investigator global assessment and had a satisfied assessment \[values of 1 (very satisfied) or 2 (quite satisfied)\] on the subject assessment.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	Baseline, Day 57	Analysis based on Modified Intent-to-Treat (mITT) population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.	percentage of change	MEAN
SECONDARY	Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound	Baseline, Day 57	Analysis based on mITT population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.	percentage of change	MEAN
SECONDARY	Change From Baseline in Consistency of the Treated Nodules at Day 57	Baseline, Day 57	Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.	units on a scale	MEAN
SECONDARY	Percent Change From Baseline in Hardness of the Treated Nodule at Day 57	Baseline, Day 57	Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.	percentage of change	MEAN
SECONDARY	Change From Baseline in Nodular Pain of the Treated Nodule at Day 57	Baseline, Day 57	Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.	units on a scale	MEAN
SECONDARY	Investigator Global Assessment of Improvement With Treatment	Day 57	Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.	units on a scale	MEAN
SECONDARY	Subject Satisfaction With Treatment	Day 57	Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.	units on a scale	MEAN
SECONDARY	Composite Responder Analysis	Day 57	Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.	participants	NUMBER

Source ClinicalTrials.gov

Results by group44

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

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	AA4500 0.60 mg	Surface Area	-81.61	Standard Deviation 20.251	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	AA4500 0.40 mg	Surface Area	-80.11	Standard Deviation 21.459	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	AA4500 0.25 mg	Surface Area	-58.30	Standard Deviation 29.849	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	Placebo	Surface Area	-41.76	Standard Deviation 32.445	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	AA4500 0.60 mg	Volume	-89.03	Standard Deviation 15.016	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	AA4500 0.40 mg	Volume	-87.58	Standard Deviation 16.372	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	AA4500 0.25 mg	Volume	-68.15	Standard Deviation 33.859	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements	Placebo	Volume	-49.13	Standard Deviation 36.736	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound	AA4500 0.60 mg	Surface Area	-34.23	Standard Deviation 41.353	percentage of change
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound	AA4500 0.40 mg	Surface Area	-19.37	Standard Deviation 39.658	percentage of change

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AA4500 0.60 mg	18
Overall Study	STARTED	AA4500 0.40 mg	18
Overall Study	STARTED	AA4500 0.25 mg	23
Overall Study	STARTED	Placebo	17
Overall Study	COMPLETED	AA4500 0.60 mg	18
Overall Study	COMPLETED	AA4500 0.40 mg	18
Overall Study	COMPLETED	AA4500 0.25 mg	22
Overall Study	COMPLETED	Placebo	16
Overall Study	NOT COMPLETED	AA4500 0.60 mg	0
Overall Study	NOT COMPLETED	AA4500 0.40 mg	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events120

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
other	Lymphadenopathy	Blood and lymphatic system disorders	AA4500 0.60 mg	1	18
other	Lymphadenopathy	Blood and lymphatic system disorders	AA4500 0.40 mg	0	18
other	Lymphadenopathy	Blood and lymphatic system disorders	AA4500 0.25 mg	0	22
other	Lymphadenopathy	Blood and lymphatic system disorders	Placebo	0	17
other	Nausea	Gastrointestinal disorders	AA4500 0.60 mg	0	18
other	Nausea	Gastrointestinal disorders	AA4500 0.40 mg	1	18
other	Nausea	Gastrointestinal disorders	AA4500 0.25 mg	0	22
other	Nausea	Gastrointestinal disorders	Placebo	0	17
other	Axillary pain	General disorders	AA4500 0.60 mg	4	18
other	Axillary pain	General disorders	AA4500 0.40 mg	1	18

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AA4500 0.60 mg
Total, all-cause mortality	AA4500 0.40 mg
Total, all-cause mortality	AA4500 0.25 mg
Total, all-cause mortality	Placebo
Total, other adverse events	AA4500 0.60 mg	17	18
Total, other adverse events	AA4500 0.40 mg	18	18
Total, other adverse events	AA4500 0.25 mg	21	22
Total, other adverse events	Placebo	7	17
Total, serious adverse events	AA4500 0.60 mg	0	18
Total, serious adverse events	AA4500 0.40 mg	0	18

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28854973	DERIVED

Source 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 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.

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