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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

Tracking Information
First Submitted Date  ICMJE July 29, 2011
First Posted Date  ICMJE August 1, 2011
Results First Submitted Date  ICMJE February 4, 2015
Results First Posted Date  ICMJE February 20, 2015
Last Update Posted Date October 5, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • Percent Change From Baseline in Total Fixed Flexion [ Time Frame: 30 days after last injection ]
    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
  • Change in Total Range of Motion [ Time Frame: 30 days after last injection ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
Percent Change From Baseline in Total Fixed Flexion [ Time Frame: Day 30 ]
Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment.
Change History Complete list of historical versions of study NCT01407068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • Subject Satisfaction With Treatment [ Time Frame: 60 days after last injection ]
    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
  • Investigator Assessment of Improvement With Treatment [ Time Frame: 60 days after last injection ]
    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
  • Clinical Success by Joint Type [ Time Frame: 30 days after injection ]
    Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2011)
  • Change From Baseline in Total Range of Motion [ Time Frame: Day 30 ]
    Total range of motion is defined as the sum of the range of motion measurements for the two joints receiving treatment. Range of motion is defined as the difference between the full flexion angle and full extension angle, expressed in degrees.
  • Subject Satisfaction With Treatment [ Time Frame: Day 60 ]
  • Investigator Assessment of Improvement With Treatment [ Time Frame: Day 60 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Administration of Two Injections for Multiple Dupuytren's Contractures
Official Title  ICMJE An Open-label Study to Assess the Safety and Efficacy of Concurrent Administration of Two Injections of AA4500 0.58 mg Into the Same Hand of Subjects With Multiple Dupuytren's Contractures
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dupuytren's Contracture
Intervention  ICMJE Biological: AA4500 collagenase clostridium histolyticum
2 concurrent injections (0.58 mg) into 2 cords on the same hand
Other Names:
  • Xiaflex
  • Xiapex
Study Arms  ICMJE Experimental: AA4500
AA4500 collagenase clostridium histolyticum
Intervention: Biological: AA4500 collagenase clostridium histolyticum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01407068
Other Study ID Numbers  ICMJE AUX-CC-864
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Veronica Urdaneta, MD, MPPH Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP