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Administration of Two Injections for Multiple Dupuytren's Contractures

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ClinicalTrials.gov Identifier: NCT01407068
Recruitment Status : Completed
First Posted : August 1, 2011
Results First Posted : February 20, 2015
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dupuytren's Contracture
Intervention Biological: AA4500 collagenase clostridium histolyticum
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AA4500
Hide Arm/Group Description

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand

Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title AA4500
Hide Arm/Group Description

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  48.3%
>=65 years
31
  51.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
63.7  (10.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
9
  15.0%
Male
51
  85.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
United States 21
Australia 39
1.Primary Outcome
Title Percent Change From Baseline in Total Fixed Flexion
Hide Description Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Time Frame 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.
Arm/Group Title AA4500
Hide Arm/Group Description:

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand

Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: percentage of contracture change
75.5  (24.11)
2.Primary Outcome
Title Change in Total Range of Motion
Hide Description The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.
Time Frame 30 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.
Arm/Group Title AA4500
Hide Arm/Group Description:

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand

Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: degrees
60.4  (21.80)
3.Secondary Outcome
Title Subject Satisfaction With Treatment
Hide Description

At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows:

  1. Very Satisfied
  2. Quite Satisfied
  3. Neither Satisfied nor Dissatisfied
  4. Quite Dissatisfied
  5. Very Dissatisfied
Time Frame 60 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.
Arm/Group Title AA4500
Hide Arm/Group Description:

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Very satisfied 36
Quite satisfied 17
Neither satisfied nor dissatisfied 5
Quite dissatisfied 1
Very dissatisfied 1
Not done 0
4.Secondary Outcome
Title Investigator Assessment of Improvement With Treatment
Hide Description

At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject’s treated finger(s) compared with screening as follows:

  1. Very Much Improved
  2. Much improved
  3. Minimally Improved
  4. No Change
  5. Minimally Worse
  6. Much Worse
  7. Very Much Worse
Time Frame 60 days after last injection
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.
Arm/Group Title AA4500
Hide Arm/Group Description:

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Very much improved 33
Much improved 22
Minimally improved 4
No change 1
Minimally worse 0
Much worse 0
Very much worse 0
Not done 0
5.Secondary Outcome
Title Clinical Success by Joint Type
Hide Description Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.
Time Frame 30 days after injection
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.
Arm/Group Title AA4500 MP AA4500 PIP
Hide Arm/Group Description:

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the metacarpophalangeal (MP) joint cord

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the interphalangeal (PIP) joint cord

Overall Number of Participants Analyzed 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Number of joints
75 45
Measure Type: Number
Unit of Measure: number of joints
Yes 57 15
No 18 30
Time Frame 60 days after injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AA4500
Hide Arm/Group Description

AA4500 collagenase clostridium histolyticum

AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand

All-Cause Mortality
AA4500
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AA4500
Affected / at Risk (%) # Events
Total   3/60 (5.00%)    
Injury, poisoning and procedural complications   
Tendonitis * 1  1/60 (1.67%)  1
Tendon rupture * 1  1/60 (1.67%)  1
Ligament injury * 1  1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  1/60 (1.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AA4500
Affected / at Risk (%) # Events
Total   60/60 (100.00%)    
Blood and lymphatic system disorders   
Lymphadenopathy * 1  22/60 (36.67%)  23
General disorders   
oedema peripheral * 1  49/60 (81.67%)  53
Injection site haematoma * 1  11/60 (18.33%)  14
Injection site swelling * 1  8/60 (13.33%)  9
Injury, poisoning and procedural complications   
Contusion * 1  48/60 (80.00%)  55
Skin laceration * 1  15/60 (25.00%)  16
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  49/60 (81.67%)  53
Skin and subcutaneous tissue disorders   
Pruritus * 1  20/60 (33.33%)  20
Blood blister * 1  7/60 (11.67%)  7
Ecchymosis * 1  3/60 (5.00%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01407068     History of Changes
Other Study ID Numbers: AUX-CC-864
First Submitted: July 29, 2011
First Posted: August 1, 2011
Results First Submitted: February 4, 2015
Results First Posted: February 20, 2015
Last Update Posted: October 5, 2017