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A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00528931
First received: September 11, 2007
Last updated: January 5, 2017
Last verified: January 2017
September 11, 2007
January 5, 2017
September 2007
December 2007   (Final data collection date for primary outcome measure)
Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500 [ Time Frame: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30 ]
AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).
Plasma concentrations of AUX I and AUX II after a single dose of AA4500 [ Time Frame: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30 ]
Complete list of historical versions of study NCT00528931 on ClinicalTrials.gov Archive Site
  • Clinical Success [ Time Frame: 30 days after treatment to the primary joint ]
    Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.
  • Clinical Improvement [ Time Frame: 30 days after treatment to the primary joint ]
    Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined.
  • Percent Change From Baseline Contracture [ Time Frame: Baseline, 30 days after treatment to the primary joint ]
    Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture.
  • Change From Baseline Range of Motion [ Time Frame: Baseline, 30 days after treatment to the primary joint ]
    Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees
  • Actual change and the percent change in degree of flexion and range of motion from baseline.
  • Safety
Not Provided
Not Provided
 
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
A Phase 1, Open-Label Study to Assess the Pharmacokinetics and Safety of a Single Injection of AA4500 0.58 mg in Subjects With Dupuytren's Contracture

A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 [NCT00528606]and AUX-CC-859 [NCT00533273]) and 7 non-pivotal studies were evaluated.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Dupuytren's Contracture
Biological: collagenase clostridium histolyticum
Single dose of AA4500 0.58 mg into the cord
Other Names:
  • XIAFLEX®
  • AA4500
Experimental: AA4500 0.58 mg
Intervention: Biological: collagenase clostridium histolyticum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2008
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
  • Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
  • Were naive to AA4500 treatment.
  • Were judged to be in good health.

Exclusion Criteria:

  • Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
  • Had received treatment for Dupuytren's contracture within 90 days of the AA4500 injection to the MP or PIP selected, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
  • Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00528931
AUX-CC-855
No
Not Provided
Not Provided
Not Provided
Endo Pharmaceuticals
Endo Pharmaceuticals
Not Provided
Study Director: Veronica Urdaneta, MD Endo Pharmaceuticals
Endo Pharmaceuticals
January 2017

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