Trial record 1 of 1 for:    NCT01407068
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Administration of Two Injections for Multiple Dupuytren's Contractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01407068
First received: July 29, 2011
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Dupuytren's Contracture
Biological: AA4500 collagenase clostridium histolyticum
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Contractures

Resource links provided by NLM:


Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:
  • Percent change from baseline in total fixed flexion [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment.


Secondary Outcome Measures:
  • Change from baseline in total range of motion [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Investigator assessment of improvement with treatment [ Time Frame: Day 60 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AA4500
AA4500 collagenase clostridium histolyticum
Biological: AA4500 collagenase clostridium histolyticum
2 concurrent injections (0.58 mg) into 2 cords on the same hand
Other Names:
  • Xiaflex
  • Xiapex

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407068

Locations
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
United States, Indiana
The Indiana Hand Center
Indianapolis, Indiana, United States, 46260
United States, New York
Department of Orthopaedics SUNY-Stony Brook
Stony Brook, New York, United States, 11794
United States, Oklahoma
Health Research Institute
Oklahoma City, Oklahoma, United States, 73109
Australia
AusTrials
Auchenflower, Australia, QLD4066
AusTrials
Auchenflower, Australia, QLD 4067
AusTrials
Kippa Ring, Australia, QLD 4020
Emeritus Research
Malvern, Australia, VIC 3144
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
Study Director: Gregory Kaufman, MD Auxilium Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01407068     History of Changes
Other Study ID Numbers: AUX-CC-864
Study First Received: July 29, 2011
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 19, 2014