Trial · NCT01674634

Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures

NCT01674634, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2015-02-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures. Trials, record NCT01674634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01674634

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Trial

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

Title: Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
NCT number: NCT01674634
Status: Completed
Phases: Phase 3
Enrollment: 715 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Dupuytren's Contracture
Interventions: XIAFLEX / XIAPEX
First posted: 2012-08-29
Last updated: 2017-10-05
Results first posted: 2015-02-20

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Total Fixed Flexion	Baseline, Day 31	Percent change from baseline in total fixed flexion = 100 \* (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.
Primary	Change From Baseline in Total Range of Motion	Baseline, Day 31	The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.
Secondary	Clinical Success	Within 30 days	Clinical success is defined as reduction of FFC of a treated joint to within 0-5 degrees of normal within 30 days of injection
Secondary	Clinical Improvement	Within 30 days	Clinical improvement is defined as a reduction of FFC by 50% or greater of the baseline value within 30 days of injection
Secondary	Subject Assessment of Satisfaction With Treatment at Day 31	Day 31	Subject's were asked to rate satisfaction with treatment at the day 31 follow-up visit
Secondary	Subject Assessment of Satisfaction With Treatment at Day 61	Day 61	Subject's were asked to rate satisfaction with treatment at the day 61 follow-up visit
Secondary	Investigator Assessment of Improvement With Treatment at Day 31	Day 31	Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 31 follow-up visit.
Secondary	Investigator Assessment of Improvement With Treatment at Day 61	Day 61	Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 61 follow-up visit.
Secondary	Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31	Baseline, Day 31	The Unité Rhumatologique des Affections de la Main (URAM) scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.
Secondary	Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61	Baseline, Day 61	The URAM scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.

Source ClinicalTrials.gov

Outcomes10

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 Total Fixed Flexion	Baseline, Day 31	Efficacy analysis was based on the modified intent-to-treat (mITT) population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on contralateral hand. Assessment is based on simultaneously treated joint pairs.	percentage of contracture change	MEAN
PRIMARY	Change From Baseline in Total Range of Motion	Baseline, Day 31	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.	degrees	MEAN
SECONDARY	Clinical Success	Within 30 days	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.	Joints	NUMBER
SECONDARY	Clinical Improvement	Within 30 days	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.	Joints	NUMBER
SECONDARY	Subject Assessment of Satisfaction With Treatment at Day 31	Day 31	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.	Joint Pairs	NUMBER
SECONDARY	Subject Assessment of Satisfaction With Treatment at Day 61	Day 61	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.	Joint Pairs	NUMBER
SECONDARY	Investigator Assessment of Improvement With Treatment at Day 31	Day 31	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.	Joint Pairs	NUMBER
SECONDARY	Investigator Assessment of Improvement With Treatment at Day 61	Day 61	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.	Joint Pairs	NUMBER
SECONDARY	Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31	Baseline, Day 31	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.	units on a scale	MEAN
SECONDARY	Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61	Baseline, Day 61	Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group40

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 Total Fixed Flexion	XIAFLEX/XIAPEX		74.41	Standard Deviation 24.83	percentage of contracture change
Change From Baseline in Total Range of Motion	XIAFLEX/XIAPEX		66.6	95% Confidence Interval 64.3 to 68.9	degrees
Clinical Success	XIAFLEX/XIAPEX MP Joint	No	317		Joints
Clinical Success	XIAFLEX/XIAPEX PIP Joint	No	394		Joints
Clinical Success	XIAFLEX/XIAPEX MP Joint	Yes	579		Joints
Clinical Success	XIAFLEX/XIAPEX PIP Joint	Yes	158		Joints
Clinical Improvement	XIAFLEX/XIAPEX MP Joint	No	96		Joints
Clinical Improvement	XIAFLEX/XIAPEX PIP Joint	No	157		Joints
Clinical Improvement	XIAFLEX/XIAPEX MP Joint	Yes	800		Joints
Clinical Improvement	XIAFLEX/XIAPEX PIP Joint	Yes	395		Joints

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	XIAFLEX/XIAPEX	715
Overall Study	COMPLETED	XIAFLEX/XIAPEX	709
Overall Study	NOT COMPLETED	XIAFLEX/XIAPEX	6

Source ClinicalTrials.gov

Adverse events35

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	Oedema peripheral	General disorders	XIAFLEX/XIAPEX	552	715	626
other	Contusion	Injury, poisoning and procedural complications	XIAFLEX/XIAPEX	420	715	513
other	Pain in extremity	Musculoskeletal and connective tissue disorders	XIAFLEX/XIAPEX	361	715	431
other	Laceration	Injury, poisoning and procedural complications	XIAFLEX/XIAPEX	184	715	192
other	Pruritus	Skin and subcutaneous tissue disorders	XIAFLEX/XIAPEX	107	715	121
other	Injection site pain	General disorders	XIAFLEX/XIAPEX	102	715	109
other	Lymphadenopathy	Blood and lymphatic system disorders	XIAFLEX/XIAPEX	92	715	102
other	Blood blister	Skin and subcutaneous tissue disorders	XIAFLEX/XIAPEX	89	715	98
other	Injection site haematoma	General disorders	XIAFLEX/XIAPEX	60	715	61
other	Axillary pain	General disorders	XIAFLEX/XIAPEX	51	715	53

1 to 10 of 35Source ClinicalTrials.gov

See all 35 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	XIAFLEX/XIAPEX
Total, other adverse events	XIAFLEX/XIAPEX	680	715
Total, serious adverse events	XIAFLEX/XIAPEX	15	715

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.

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