Clinical trial NCT00528840: Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Official title: A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Dupuytren's Disease
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for evaluation and injection were enrolled.

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 advanced Dupuytren's disease, 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 naïve to AA4500 treatment or had received one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855.
* 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 advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
* 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: Reduction in Contracture to 5° or Less
timeFrame: Within 30 days after the last injection
Secondary outcomes:
measure: Clinical Improvement After the Last Injection
timeFrame: Baseline; within 30 days after last injection
measure: Percent Reduction From Baseline Contracture After the Last Injection
timeFrame: Baseline, within 30 days after last injection
measure: Change From Baseline Range of Motion After the Last Injection
timeFrame: Baseline, 30 days after last injection
measure: Time to Reach Clinical Success
timeFrame: First evaluation visit on which clinical success is achieved through the Day 30 evaluation
measure: Clinical Success After the First Injection
timeFrame: Within 30 days after first injection
measure: Clinical Improvement After the First Injection
timeFrame: Baseline; within 30 days after first injection
measure: Percent Reduction From Baseline Contracture After the First Injection
timeFrame: Baseline; within 30 days after first injection
measure: Change From Baseline Range of Motion After the First Injection
timeFrame: Baseline; within 30 days after first injection
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopedic Institute, P.C.
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Effingham
country: United States
facility: Southern Illinois Hand Center, S.C.
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: The Indiana Hand Center
state: Indiana
city: Wichita
country: United States
facility: Pri Via
state: Kansas
city: Bismarck
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Mayfield
country: United States
facility: David R. Mandel, Inc.
state: Ohio
city: Portland
country: United States
facility: St. Vincent Medical Center
state: Oregon
city: Erie
country: United States
facility: Hamot Center for Clinical Research
state: Pennsylvania
city: Clarksville
country: United States
facility: Alpha Clinical Research
state: Tennessee
city: Houston
country: United States
facility: The Rheumatic Disease Clinic of Houston
state: Texas
city: Houston
country: United States
facility: Accurate Clincal Research
state: Texas
Study officials:
affiliation: Endo Pharmaceuticals
name: Veronica Urdaneta, MD
role: STUDY_DIRECTOR
References: