Trial Outcomes & Findings for Administration of Two Injections for Multiple Dupuytren's Contractures (NCT NCT01407068)

NCT ID: NCT01407068

Last Updated: 2017-10-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: 30 days after last injection
• Results posted on: 2017-10-05

Participant Flow

Participant milestones

Measure	AA4500 AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Administration of Two Injections for Multiple Dupuytren's Contractures

Baseline characteristics by cohort

Measure	AA4500 n=60 Participants AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 10.59 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Region of Enrollment Australia	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after last injection

Population: 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.

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

Outcome measures

Measure	AA4500 n=60 Participants AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand	AA4500 PIP 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
Percent Change From Baseline in Total Fixed Flexion	75.5 percentage of contracture change Standard Deviation 24.11	—

PRIMARY outcome

Timeframe: 30 days after last injection

Population: 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.

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.

Outcome measures

Measure	AA4500 n=60 Participants AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand	AA4500 PIP 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
Change in Total Range of Motion	60.4 degrees Standard Deviation 21.80	—

SECONDARY outcome

Timeframe: 60 days after last injection

Population: 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.

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

Outcome measures

Measure	AA4500 n=60 Participants AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand	AA4500 PIP 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
Subject Satisfaction With Treatment Very satisfied	36 participants	—
Subject Satisfaction With Treatment Quite satisfied	17 participants	—
Subject Satisfaction With Treatment Neither satisfied nor dissatisfied	5 participants	—
Subject Satisfaction With Treatment Quite dissatisfied	1 participants	—
Subject Satisfaction With Treatment Very dissatisfied	1 participants	—
Subject Satisfaction With Treatment Not done	0 participants	—

SECONDARY outcome

Timeframe: 60 days after last injection

Population: 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.

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

Outcome measures

Measure	AA4500 n=60 Participants AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand	AA4500 PIP 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
Investigator Assessment of Improvement With Treatment Very much improved	33 participants	—
Investigator Assessment of Improvement With Treatment Much improved	22 participants	—
Investigator Assessment of Improvement With Treatment Minimally improved	4 participants	—
Investigator Assessment of Improvement With Treatment No change	1 participants	—
Investigator Assessment of Improvement With Treatment Minimally worse	0 participants	—
Investigator Assessment of Improvement With Treatment Much worse	0 participants	—
Investigator Assessment of Improvement With Treatment Very much worse	0 participants	—
Investigator Assessment of Improvement With Treatment Not done	0 participants	—

SECONDARY outcome

Timeframe: 30 days after injection

Population: 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.

Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.

Outcome measures

Measure	AA4500 n=75 Number of joints AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand	AA4500 PIP n=45 Number of joints 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
Clinical Success by Joint Type Yes	57 number of joints	15 number of joints
Clinical Success by Joint Type No	18 number of joints	30 number of joints

Adverse Events

AA4500

Serious events: 3 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Measure	AA4500 n=60 participants at risk AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand
Musculoskeletal and connective tissue disorders Pain in extremity	1.7% 1/60 • Number of events 1 • 60 days after injection
Injury, poisoning and procedural complications Tendonitis	1.7% 1/60 • Number of events 1 • 60 days after injection
Injury, poisoning and procedural complications Tendon rupture	1.7% 1/60 • Number of events 1 • 60 days after injection
Injury, poisoning and procedural complications Ligament injury	1.7% 1/60 • Number of events 1 • 60 days after injection

Other adverse events

Measure	AA4500 n=60 participants at risk AA4500 collagenase clostridium histolyticum AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand
General disorders oedema peripheral	81.7% 49/60 • Number of events 53 • 60 days after injection
Musculoskeletal and connective tissue disorders Pain in extremity	81.7% 49/60 • Number of events 53 • 60 days after injection
Injury, poisoning and procedural complications Contusion	80.0% 48/60 • Number of events 55 • 60 days after injection
Blood and lymphatic system disorders Lymphadenopathy	36.7% 22/60 • Number of events 23 • 60 days after injection
Skin and subcutaneous tissue disorders Pruritus	33.3% 20/60 • Number of events 20 • 60 days after injection
Injury, poisoning and procedural complications Skin laceration	25.0% 15/60 • Number of events 16 • 60 days after injection
General disorders Injection site haematoma	18.3% 11/60 • Number of events 14 • 60 days after injection
General disorders Injection site swelling	13.3% 8/60 • Number of events 9 • 60 days after injection
Skin and subcutaneous tissue disorders Blood blister	11.7% 7/60 • Number of events 7 • 60 days after injection
Skin and subcutaneous tissue disorders Ecchymosis	5.0% 3/60 • Number of events 3 • 60 days after injection

Additional Information

Clinical Trial Coordinator

Endo Pharmaceuticals, Inc.

Email: clinicalsite.inquiries@endo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER