Clinical trial NCT00528931: A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dupuytren's Contracture
Keywords: Assessment of AUX I and/or AUX II in human plasma
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500
timeFrame: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30
Secondary outcomes:
measure: Clinical Success
timeFrame: 30 days after treatment to the primary joint
measure: Clinical Improvement
timeFrame: 30 days after treatment to the primary joint
measure: Percent Change From Baseline Contracture
timeFrame: Baseline, 30 days after treatment to the primary joint
measure: Change From Baseline Range of Motion
timeFrame: Baseline, 30 days after treatment to the primary joint
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
Study officials:
affiliation: Endo Pharmaceuticals
name: Veronica Urdaneta, MD
role: STUDY_DIRECTOR
References: