Clinical Trial: Administration of Two Injections for Multiple Dupuytren's Contractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Co

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 Summary:

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.

Sponsor: Endo Pharmaceuticals

Current Primary Outcome:

• 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: Percent Change From Baseline in Total Fixed Flexion [ Time Frame: Day 30 ]

Current Secondary Outcome:

• 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:

• 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 ]

Information By: Endo Pharmaceuticals

Dates:
Date Received: July 29, 2011
Date Started: September 2011
Date Completion:
Last Updated: September 14, 2016
Last Verified: August 2016