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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01407068
Other study ID # AUX-CC-864
Secondary ID
Status Completed
Phase Phase 3
First received July 29, 2011
Last updated September 7, 2017
Start date September 2011
Est. completion date February 2012

Study information

Verified date September 2017
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this study are to assess the safety and efficacy of concurrent administration of two injections of AA4500 into the same hand of subjects with multiple Dupuytren's contractures caused by palpable cords.


Description:

Methodology/Study Design:

This is an open-label, study in men and women with multiple Dupuytren's contractures. Approximately 60 subjects who have at least two Dupuytren's contractures caused by palpable cords in the same hand will be enrolled.

After all pre-injection procedures are completed on Day 1, eligible men and women will receive two concurrent injections of AA4500 0.58 mg into the same hand. On Day 2, a finger extension procedure to facilitate cord disruption will be performed in those subjects who do not have spontaneous disruption of their cord(s). Follow-up visits for the evaluation of safety and efficacy will be on Day 8, Day 30, and Day 60.

Upon completion of the Day 60 follow-up visit, subjects who require further treatment will have the option to receive three additional open-label treatments according to the XIAFLEX package insert (Appendix C). Subjects may receive up to a total of five injections and individual cords may receive up to a total of three injections.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Provide written informed consent

2. Be a man or woman = 18 years of age

3. Have a diagnosis of Dupuytren's disease and have at least 2 fixed-flexion contractures on the same hand that are = 20º in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cords suitable for treatment

4. Have a positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top

5. Either be using an accepted method of birth control (ie, surgical sterilization; intra uterine contraceptive device; oral contraceptive; diaphragm or condom in combination with contraceptive cream, or jelly or foam) and have negative pregnancy testing before administration of AA4500, if a female of childbearing potential, or be a postmenopausal female (no menses for at least 1 year or hysterectomy)

6. Not have any clinically significant medical history or condition(s) that would, in the opinion of the investigator, substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives of the study

7. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria:

1. Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 90 days before the first injection of AA4500

2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands

3. Has a known systemic allergy to collagenase or any other excipient of AA4500

4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX/XIAPEX) within 30 days before injection of AA4500

5. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for = 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs [NSAIDs]) within 7 days before injection of AA4500)

6. Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study

7. Is known to be immunocompromised or human immunodeficiency virus (HIV) positive

8. Has a history of illicit drug abuse or alcoholism within the year before injection of AA4500

9. Received an investigational drug within 30 days before injection of AA4500

10. Is a pregnant or lactating female

11. Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives of the study

12. Has jewelry on the hand to be treated that cannot be removed

Study Design


Intervention

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

Locations

Country Name City State
Australia AusTrials Auchenflower
Australia AusTrials Auchenflower
Australia AusTrials Kippa Ring
Australia Emeritus Research Malvern
United States The Indiana Hand Center Indianapolis Indiana
United States Health Research Institute Oklahoma City Oklahoma
United States Department of Orthopaedics SUNY-Stony Brook Stony Brook New York
United States Tucson Orthopaedic Institute Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Total Fixed Flexion 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 30 days after last injection
Primary Change in Total Range of Motion 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. 30 days after last injection
Secondary Subject Satisfaction With Treatment At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows:
Very Satisfied
Quite Satisfied
Neither Satisfied nor Dissatisfied
Quite Dissatisfied
Very Dissatisfied
60 days after last injection
Secondary Investigator Assessment of Improvement With Treatment 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:
Very Much Improved
Much improved
Minimally Improved
No Change
Minimally Worse
Much Worse
Very Much Worse
60 days after last injection
Secondary Clinical Success by Joint Type Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500. 30 days after injection
See also
  Status Clinical Trial Phase
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Completed NCT01674634 - Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures Phase 3
Completed NCT00528931 - A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture Phase 1
Completed NCT00565019 - Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture Phase 3
Completed NCT01588353 - Collagenase Option for Reduction of Dupuytren's Contracture in Japan Phase 3
Completed NCT00468949 - Health-Related Quality of Life in Patients With Dupuytren's Disease Phase 1
Completed NCT01444729 - Post Approval Commitment Study N/A
Terminated NCT05877066 - Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Completed NCT01229436 - Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) Phase 3
Completed NCT01265420 - Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb Phase 4
Completed NCT00931567 - Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing Phase 2/Phase 3
Completed NCT00528606 - AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture Phase 3
Completed NCT00004409 - Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease Phase 2
Completed NCT00014742 - Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease Phase 3